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MDD - UniqueEdge · MDD – Product List Product List for Certificate No: 41377486-01 Date: 09...
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Transcript of MDD - UniqueEdge · MDD – Product List Product List for Certificate No: 41377486-01 Date: 09...
MDD – Product List
Product List for Certificate No: 41377486-01 Date: 09 March 2019
Page 1 of 19
Intertek Semko AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden
Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www.intertek.se Registered in Sweden: No SE556024059901, Registered office: As address
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Products included in the certificate no: 41377486-01
Issued to: Unique Technologies, Inc.
111 Chestnut Street Mohnton, PA 19540 USA
Product category Type/Model designation
Class Sterile GMDN code
(not mandatory)
Date added
Ophthalmic microsurgical knives
1.2 mm Double Bevel AK Slit Knife Angled 52-1252
IIa Yes 46741
29 June 2018
1.2 mm Double Bevel AK Slit Knife Angled 52-1252-G
IIa Yes 46741
29 June 2018
1.8 mm Double Bevel AK Slit Knife Angled 52-1852
IIa Yes 46741
29 June 2018
2.2 mm AK MicroPhaco Slit Knife Angled 52-2250
IIa Yes 46741
29 June 2018
2.2 mm AK Double Bevel Slit Knife Angled 52-2252
IIa Yes 46741
29 June 2018
2.4 mm AK Slit Knife Angled 52-2450
IIa Yes 46741
29 June 2018
2.4 mm AK Double Bevel Slit Knife Angled 52-2452
IIa Yes 46741
29 June 2018
2.5 mm AK Double Bevel Slit Knife Angled 52-2552
IIa Yes 46741
29 June 2018
2.5 mm AK Double Bevel Slit Knife Angled 52-2552-G
IIa Yes 46741
29 June 2018
2.65 mm AK Double Bevel Slit Knife Angled 52-2652
IIa Yes 46741
29 June 2018
2.65 mm AK Double Bevel Slit Knife Angled 52-2652-G
IIa Yes 46741
29 June 2018
2.75 mm AK Slit Knife Angled 52-2750
IIa Yes 46741
29 June 2018
2.75 mm AK Double Bevel Slit Knife Angled 52-2752
IIa Yes 46741
29 June 2018
MDD – Product List
Product List for Certificate No: 41377486-01 Date: 09 March 2019
Page 2 of 19
Intertek Semko AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden
Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www.intertek.se Registered in Sweden: No SE556024059901, Registered office: As address
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Product category Type/Model designation
Class Sterile GMDN code
(not mandatory)
Date added
2.85 mm AK Slit Knife Angled 52-2850
IIa Yes 46741
29 June 2018
2.85 mm AK Slit Knife Angled 52-2850-G
IIa Yes 46741
29 June 2018
2.8 mm AK Slit Knife Angled 52-2851
IIa Yes 46741
29 June 2018
3.0 mm AK Slit Knife Angled 52-3050
IIa Yes 46741
29 June 2018
3.2 mm AK Slit Knife Angled 52-3250
IIa Yes 46741
29 June 2018
1.4 mm MicroPhaco Slit Knife Angled 52-1463
IIa Yes 46741
29 June 2018
1.5 mm MicroPhaco Slit Knife Angled 52-1563
IIa Yes 46741
29 June 2018
1.8 mm MicroPhaco Slit Knife Angled 52-1863
IIa Yes 46741
29 June 2018
2.0 mm MicroPhaco Slit Knife Angled 52-2063
IIa Yes 46741
29 June 2018
2.0 mm MicroPhaco Slit Knife, Angled, Guarded 52-2063-G
IIa Yes 46741
29 June 2018
2.2 mm MicroPhaco Slit Knife Angled 52-2261
IIa Yes 46741
29 June 2018
2.2 mm MicroPhaco Slit Knife, Angled, Guarded 52-2261-G
IIa Yes 46741
29 June 2018
2.2 mm MicroPhaco Slit Knife, Angled (bulk) 52-2261-NS
IIa No 46741
29 June 2018
2.2 mm CMP Knife Angled, Double Bevel 52-2263
IIa Yes 46741
29 June 2018
2.2 mm CMP Knife Angled, Double Bevel, Guarded 52-2263-G
IIa Yes 46741
29 June 2018
2.4 mm Slit Knife Angled, Double Bevel 52-2431
IIa Yes 46741
29 June 2018
MDD – Product List
Product List for Certificate No: 41377486-01 Date: 09 March 2019
Page 3 of 19
Intertek Semko AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden
Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www.intertek.se Registered in Sweden: No SE556024059901, Registered office: As address
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Product category Type/Model designation
Class Sterile GMDN code
(not mandatory)
Date added
2.4 mm Slit Knife Angled 52-2461
IIa Yes 46741
29 June 2018
2.4 mm Slit Knife Angled, Guarded 52-2461-G
IIa Yes 46741
29 June 2018
2.4 mm Slit Knife Angled (bulk) 52-2461-NS
IIa No 46741
29 June 2018
2.5 mm Slit Knife Angled, Double Bevel 52-2531
IIa Yes 46741
29 June 2018
2.5 mm Slit Knife Angled, Double Bevel (bulk) 52-2531G-NS
IIa No 46741
29 June 2018
2.5 mm Slit Knife Angled, Double Bevel (bulk) 52-2531-NS
IIa No 46741
29 June 2018
2.5 mm Slit Knife Angled 52-2561
IIa Yes 46741
29 June 2018
2.5 mm Slit Knife, Angled, Guarded 52-2561-G
IIa Yes 46741
29 June 2018
2.65 mm Slit Knife Angled, Double Bevel 52-2631
IIa Yes 46741
29 June 2018
2.65 mm Slit Knife Angled 52-2661
IIa Yes 46741
29 June 2018
2.65 mm Slit Knife Angled, Guarded 52-2661-G
IIa Yes 46741
29 June 2018
2.65 mm Slit Knife Angled (bulk) 52-2661-NS
IIa No 46741
29 June 2018
2.75 mm Slit Knife Straight 52-2701
IIa Yes 46741
29 June 2018
2.75 mm Slit Knife Angled, Double Bevel 52-2731
IIa Yes 46741
29 June 2018
2.75 mm Slit Knife Angled 52-2761
IIa Yes 46741
29 June 2018
2.75 mm Slit Knife Angled, Guarded 52-2761-G
IIa Yes 46741
29 June 2018
MDD – Product List
Product List for Certificate No: 41377486-01 Date: 09 March 2019
Page 4 of 19
Intertek Semko AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden
Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www.intertek.se Registered in Sweden: No SE556024059901, Registered office: As address
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Product category Type/Model designation
Class Sterile GMDN code
(not mandatory)
Date added
2.75 mm Slit Knife Angled (bulk) 52-2761-NS
IIa No 46741
29 June 2018
2.8 mm Slit Knife Straight 52-2801
IIa Yes 46741
29 June 2018
2.8 mm Slit Knife Angled 52-2808
IIa Yes 46741
29 June 2018
2.8 mm Slit Knife Angled, Guarded 52-2808-G
IIa Yes 46741
29 June 2018
2.8 mm Slit Knife Angled (bulk) 52-2808-NS
IIa No 46741
29 June 2018
2.8 mm Slit Knife Angled, Double Bevel 52-2830
IIa Yes 46741
29 June 2018
2.85 mm Slit Knife Angled, Double Bevel 52-2831
IIa Yes 46741
29 June 2018
2.85 mm Slit Knife Angled 52-2861
IIa Yes 46741
29 June 2018
2.85 mm Slit Knife Angled, Guarded 52-2861-G
IIa Yes 46741
29 June 2018
3.0 mm Slit Knife Straight 52-2901
IIa Yes 46741
29 June 2018
3.0 mm Slit Knife Angled, Double Bevel 52-2931
IIa Yes 46741
29 June 2018
3.0 mm Slit Knife Angled 52-2961
IIa Yes 46741
29 June 2018
3.0 mm Slit Knife Angled, Guarded 52-2961-G
IIa Yes 46741
29 June 2018
3.2 mm Slit Knife Straight 52-3201
IIa Yes 46741
29 June 2018
3.2 mm Slit Knife Angled, Double Bevel 52-3231
IIa Yes 46741
29 June 2018
3.2 mm Slit Knife Angled 52-3261
IIa Yes 46741
29 June 2018
3.2 mm Slit Knife, Angled, Guarded 52-3261-G
IIa Yes 46741
29 June 2018
MDD – Product List
Product List for Certificate No: 41377486-01 Date: 09 March 2019
Page 5 of 19
Intertek Semko AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden
Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www.intertek.se Registered in Sweden: No SE556024059901, Registered office: As address
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Product category Type/Model designation
Class Sterile GMDN code
(not mandatory)
Date added
3.2 mm Slit Knife Angled (bulk) 52-3261-NS
IIa No 46741
29 June 2018
3.5 mm Slit Knife Angled 52-3561
IIa Yes 46741
29 June 2018
3.5 mm Slit Knife Angled, Guarded 52-3561-G
IIa Yes 46741
29 June 2018
5.2 mm Slit Knife Angled 52-5261
IIa Yes 46741
29 June 2018
2.5 mm Clear Corneal Knife Angled 52-2563
IIa Yes 46741
29 June 2018
2.65 mm SC Clear Corneal Knife Angled 52-2635
IIa Yes 46741
29 June 2018
2.65 mm SC Clear Corneal Knife, Angled, Guarded 52-2635-G
IIa Yes 46741
29 June 2018
2.65 mm Clear Corneal Knife Angled 52-2663
IIa Yes 46741
29 June 2018
2.75 mm SC Clear Corneal Knife Angled 52-2735
IIa Yes 46741
29 June 2018
2.75 mm SC Clear Corneal Knife, Angled (bulk) 52-2735-NS
IIa No 46741
29 June 2018
2.75 mm Clear Corneal Knif, Angled 52-2763
IIa Yes 46741
29 June 2018
2.75 mm Clear Corneal Knife, Angled, Guarded 52-2763-G
IIa Yes 46741
29 June 2018
2.85 mm SC Clear Corneal Knif, Angled 52-2835
IIa Yes 46741
29 June 2018
2.85 mm Clear Corneal Knife Angled 52-2863
IIa Yes 46741
29 June 2018
3.0 mm SC Clear Corneal Knife Angled 52-3035
IIa Yes 46741
29 June 2018
3.0 mm Clear Corneal Knife Angled 52-3063
IIa Yes 46741
29 June 2018
MDD – Product List
Product List for Certificate No: 41377486-01 Date: 09 March 2019
Page 6 of 19
Intertek Semko AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden
Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www.intertek.se Registered in Sweden: No SE556024059901, Registered office: As address
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Product category Type/Model designation
Class Sterile GMDN code
(not mandatory)
Date added
3.2 mm SC Clear Corneal Knife Angled 52-3235
IIa Yes 46741
29 June 2018
3.2 mm Clear Corneal Knife Angled 52-3263
IIa Yes 46741
29 June 2018
15 Deg. Stab Knife 52-1501
IIa Yes 46741
29 June 2018
15 Deg. Stab Knife Guarded 52-1501-G
IIa Yes 46741
29 June 2018
15 Deg. Stab Knife (bulk) 52-1501-NS
IIa No 46741
29 June 2018
15 Deg. 3 mm Restricted Depth Stab Knife 52-1531
IIa Yes 46741
29 June 2018
15 Deg. 5mm Restricted Depth Stab Knife 52-1551
IIa Yes 46741
29 June 2018
22.5 Deg Stab Knife 52-2201
IIa Yes 46741
29 June 2018
22.5 Deg. Stab Knife Guarded 52-2201-G
IIa Yes 46741
29 June 2018
22.5 Deg. 4 mm Restricted Depth Stab Knife 52-2241
IIa Yes 46741
29 June 2018
30 Deg. Stab Knife 52-3001
IIa Yes 46741
29 June 2018
30 Deg. Stab Knife Guarded 52-3001-G
IIa Yes 46741
29 June 2018
30 Deg. 3.5 mm Restricted Depth Stab Knife 52-3036
IIa Yes 46741
29 June 2018
30 Deg. 5 mm Restricted Depth Stab Knife 52-3051
IIa Yes 46741
29 June 2018
45 Deg. Stab Knife 52-4501
IIa Yes 46741
29 June 2018
45 Deg. Stab Knife Guarded 52-4501-G
IIa Yes 46741
29 June 2018
45 Deg. Stab Knife (bulk) 52-4501-G-NS
IIa No 46741
29 June 2018
MDD – Product List
Product List for Certificate No: 41377486-01 Date: 09 March 2019
Page 7 of 19
Intertek Semko AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden
Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www.intertek.se Registered in Sweden: No SE556024059901, Registered office: As address
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Product category Type/Model designation
Class Sterile GMDN code
(not mandatory)
Date added
45 Deg. Stab Knife (bulk) 52-4501-NS
IIa No 46741
29 June 2018
300 Micron Precision Depth Knife 52-0300
IIa Yes 46741
29 June 2018
350 Micron Precision Depth Knife 52-0350
IIa Yes 46741
29 June 2018
550 Micron Precision Depth Knife 52-0550
IIa Yes 46741
29 June 2018
600 Micron Precision Depth Knife 52-0600
IIa Yes 46741
29 June 2018
2.0 mm Crescent Knife, Straight 54-1000
IIa Yes 46741
29 June 2018
2.0 mm Crescent Knife Angled 54-1010
IIa Yes 46741
29 June 2018
2.0 mm Crescent Knife, Angled, Guarded 54-1010-G
IIa Yes 46741
29 June 2018
2.2 mm Crescent Knife Angled 54-1012
IIa Yes 46741
29 June 2018
2.2 mm Crescent Knife, Angled, Guarded 54-1012-G
IIa Yes 46741
29 June 2018
2.3 mm Crescent Knife Angled 54-1013
IIa Yes 46741
29 June 2018
2.0 mm Crescent Knife, Angled, Bevel Down 54-1020
IIa Yes 46741
29 June 2018
2.0 mm Crescent Knife, Angled, Double Bevel 54-1031
IIa Yes 46741
29 June 2018
1.25 mm Mini Crescent Knife Angled 54-1060
IIa Yes 46741
29 June 2018
2.2 mm Spoon Knife Angled 54-2261
IIa Yes 46741
29 June 2018
3.0 mm Spoon Knife Angled 54-3061
IIa Yes 46741
29 June 2018
MDD – Product List
Product List for Certificate No: 41377486-01 Date: 09 March 2019
Page 8 of 19
Intertek Semko AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden
Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www.intertek.se Registered in Sweden: No SE556024059901, Registered office: As address
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Product category Type/Model designation
Class Sterile GMDN code
(not mandatory)
Date added
3.5 mm Implant Knife Angled 56-3561
IIa Yes 46741
29 June 2018
4.0 mm Implant Knife Angled 56-4061
IIa Yes 46741
29 June 2018
5.2 mm Implant Knife Angled 56-5261
IIa Yes 46741
29 June 2018
3.2 mm Implant Knife Angled 56-5361
IIa Yes 46741
29 June 2018
1.2 x 1.4 mm Trapezoid Knife Angled 55-1214
IIa Yes 46741
29 June 2018
1.4 x 1.6 mm Trapezoid Knife Angled 55-1416
IIa Yes 46741
29 June 2018
1.5 x 1.7 mm Trapezoid Knife Angled 55-1517
IIa Yes 46741
29 June 2018
1.5 x 2.0 mm Trapezoid Knife Angled 55-1520
IIa Yes 46741
29 June 2018
1.6 x 1.8 mm Trapezoid Knife Angled 55-1618
IIa Yes 46741
29 June 2018
1.7 x 2.0 mm Trapezoid Knife Angled 55-1720
IIa Yes 46741
29 June 2018
1.8 x 2.2 mm Trapezoid Knife Angled 55-1822
IIa Yes 46741
29 June 2018
2.0 x 2.2 mm Trapezoid Knife Angled 55-2022
IIa Yes 46741
29 June 2018
2.0 x 2.2 mm Trapezoid Knife Angled (bulk) 55-2022-NS
IIa No 46741 29 June 2018
2.5 x 2.9 mm Trapezoid Knife Angled 55-2522
IIa Yes 46741
29 June 2018
MDD – Product List
Product List for Certificate No: 41377486-01 Date: 09 March 2019
Page 9 of 19
Intertek Semko AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden
Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www.intertek.se Registered in Sweden: No SE556024059901, Registered office: As address
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Product category Type/Model designation
Class Sterile GMDN code
(not mandatory)
Date added
2.5 x 3.2 mm Trapezoid Knife Angled 55-2524
IIa Yes 46741
29 June 2018
2.75 x 3.0 mm Trapezoid Knife Angled 55-2723
IIa Yes 46741
29 June 2018
2.75 x 3.2 mm Trapezoid Knife Angled 55-2724
IIa Yes 46741
29 June 2018
2.85 x 3.2 mm Trapezoid Knife Angled 55-2824
IIa Yes 46741
29 June 2018
2.85 x 3.5 mm Trapezoid Knife Angled 55-2825
IIa Yes 46741
29 June 2018
2.85 x 3.75 mm Trapezoid Knife Angled 55-2826
IIa Yes 46741
29 June 2018
3.0 x 3.2 mm Trapezoid Knife Angled 55-2924
IIa Yes 46741
29 June 2018
0.8 mm (23G) MVR Sideport Knife, Angled 58-2008
IIa Yes 46741
29 June 2018
1.0 mm MVR Sideport Knife Angled 58-2010
IIa Yes 46741
29 June 2018
1.0 mm MVR Sideport Knife, Angled, Guarded 58-2010-G
IIa Yes 46741
29 June 2018
1.0 mm Sideport MVR Style Knife, Angled (bulk) 58-2010-NS
IIa No 46741 29 June 2018
1.1 mm MVR Sideport Knife Angled 58-2011
IIa Yes 46741
29 June 2018
1.1 mm MVR Sideport Knife, Angled, Guarded 58-2011-G
IIa Yes 46741
29 June 2018
1.2 mm (20G) MVR Sideport Knife, Angled 58-2012
IIa Yes 46741
29 June 2018
MDD – Product List
Product List for Certificate No: 41377486-01 Date: 09 March 2019
Page 10 of 19
Intertek Semko AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden
Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www.intertek.se Registered in Sweden: No SE556024059901, Registered office: As address
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Product category Type/Model designation
Class Sterile GMDN code
(not mandatory)
Date added
1.2 mm (20G) MVR Sideport Knife, Angled, Guarded 58-2012-G
IIa Yes 46741
29 June 2018
1.2 mm (20G) MVR Sideport Knife, Angled (bulk) 58-2012-NS
IIa No 46741 29 June 2018
1.4 mm (19G) MVR Sideport Knife, Angled 58-2014
IIa Yes 46741
29 June 2018
1.5 mm MVR Sideport Knife Angled 58-2015
IIa Yes 46741
29 June 2018
0.8 mm (23G) MVR Sideport Knife, Straight 58-2308
IIa Yes 46741
29 June 2018
1.2 mm (20G) MVR Sideport Knife, Straight 58-2312
IIa Yes 46741
29 June 2018
1.2 mm (20G) MVR Sideport Knife, Straight, Guarded 58-2312-G
IIa Yes 46741
29 June 2018
1.4 mm (19G) MVR Sideport Knife, Straight 58-2314
IIa Yes 46741
29 June 2018
1.1 mm AK Sideport Knife Angled 58-3011
IIa Yes 46741
29 June 2018
19 Gauge Vitrectomy Knife, Straight 51-1901
IIa Yes 46741
29 June 2018
19 Gauge Vitrectomy Knife, Straight (bulk) 51-1901-NS
IIa No 46741 29 June 2018
20 Gauge Vitrectomy Knife, Straight 51-2001
IIa Yes 46741
29 June 2018
20 Gauge Vitrectomy Knife, Straight (bulk) 51-2001-NS
IIa No 46741 29 June 2018
20 Gauge Vitrectomy Knife Angled 51-2061
IIa Yes 46741
29 June 2018
23 Gauge Vitrectomy Knife, Straight 51-2301
IIa Yes 46741
29 June 2018
MDD – Product List
Product List for Certificate No: 41377486-01 Date: 09 March 2019
Page 11 of 19
Intertek Semko AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden
Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www.intertek.se Registered in Sweden: No SE556024059901, Registered office: As address
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Product category Type/Model designation
Class Sterile GMDN code
(not mandatory)
Date added
23 Gauge Vitrectomy Knife Angled 51-2361
IIa Yes 46741
29 June 2018
25 Gauge Vitrectomy Knife, Straight 51-2501
IIa Yes 46741
29 June 2018
25 Gauge Vitrectomy Knife Angled 51-2531
IIa Yes 46741
29 June 2018
1.0 mm UniBevel Slit Knife Angled 52-1040
IIa Yes 46741
29 June 2018
1.0 mm UniBevel Slit Knife, Angled, Guarded 52-1040-G
IIa Yes 46741
29 June 2018
1.2 mm UniBevel Slit Knife Angled 52-1240
IIa Yes 46741
29 June 2018
1.4 mm UniBevel Slit Knife Angled 52-1440
IIa Yes 46741
29 June 2018
1.6 mm UniBevel Slit Knife Angled 52-1640
IIa Yes 46741
29 June 2018
1.8 mm UniBevel Slit Knife Angled 52-1840
IIa Yes 46741
29 June 2018
1.8 mm UniBevel Slit Knife, Angled, Guarded 52-1840G
IIa Yes 46741
29 June 2018
2.0 mm UniBevel Slit Knife Angled 52-2040
IIa Yes 46741
29 June 2018
2.0 mm UniBevel Slit Knife, Angled, Guarded 52-2040-G
IIa Yes 46741
29 June 2018
2.2 mm UniBevel Slit Knife Angled 52-2240
IIa Yes 46741
29 June 2018
2.2 mm UniBevel Slit Knife, Angled, Guarded 52-2240-G
IIa Yes 46741
29 June 2018
2.2 mm UniBevel Clear Corneal Knife Angled 52-2242
IIa Yes 46741
29 June 2018
2.4 mm UniBevel Slit Knife Angled 52-2440
IIa Yes 46741
29 June 2018
MDD – Product List
Product List for Certificate No: 41377486-01 Date: 09 March 2019
Page 12 of 19
Intertek Semko AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden
Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www.intertek.se Registered in Sweden: No SE556024059901, Registered office: As address
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Product category Type/Model designation
Class Sterile GMDN code
(not mandatory)
Date added
2.4 mm UniBevel Slit Knife, Angled, Guarded 52-2440-G
IIa Yes 46741
29 June 2018
2.4 mm UniBevel Clear Corneal Knife Angled 52-2442
IIa Yes 46741
29 June 2018
2.5 mm UniBevel Slit Knife Angled 52-2540
IIa Yes 46741
29 June 2018
2.5mm UniBevel Slit Knife, Angled, Guarded 52-2540-G
IIa Yes 46741
29 June 2018
2.5 mm UniBevel Clear Corneal Knife Angled 52-2542
IIa Yes 46741
29 June 2018
2.65 mm UniBevel Slit Knife Angled 52-2640
IIa Yes 46741
29 June 2018
2.65 mm UniBevel Slit Knife, Angled, Guarded 52-2640-G
IIa Yes 46741
29 June 2018
2.65 mm UniBevel Clear Corneal Knife Angled 52-2642
IIa Yes 46741
29 June 2018
2.75 mm UniBevel Slit Knife Angled 52-2740
IIa Yes 46741
29 June 2018
2.75mm UniBevel Slit Knife, Angled, Guarded 52-2740-G
IIa Yes 46741
29 June 2018
2.75 mm UniBevel Slit Knife Angled (bulk) 52-2740-NS
IIa No 46741 29 June 2018
2.75 mm UniBevel Clear Corneal Knife Angled 52-2742
IIa Yes 46741
29 June 2018
2.85 mm UniBevel Slit Knife Angled 52-2840
IIa Yes 46741
29 June 2018
2.85 mm UniBevel Clear Corneal Knife Angled 52-2842
IIa Yes 46741
29 June 2018
MDD – Product List
Product List for Certificate No: 41377486-01 Date: 09 March 2019
Page 13 of 19
Intertek Semko AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden
Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www.intertek.se Registered in Sweden: No SE556024059901, Registered office: As address
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Product category Type/Model designation
Class Sterile GMDN code
(not mandatory)
Date added
2.8 mm UniBevel Slit Knife Angled 52-2848
IIa Yes 46741
29 June 2018
2.8 mm UniBevel Slit Knife, Angled, Guarded 52-2848-G
IIa Yes 46741
29 June 2018
3.0 mm UniBevel Slit Knife Angled 52-3040
IIa Yes 46741
29 June 2018
3.0 mm UniBevel Slit Knife, Angled, Guarded 52-3040-G
IIa Yes 46741
29 June 2018
3.0 mm UniBevel Clear Corneal Knife Angled 52-3042
IIa Yes 46741
29 June 2018
3.0 mm UniBevel Clear Corneal Knife, Angled, Guarded 52-3042-G
IIa Yes 46741
29 June 2018
3.2 mm UniBevel Slit Knife Angled 52-3240
IIa Yes 46741
29 June 2018
3.2 mm UniBevel Slit Knife, Angled, Guarded 52-3240-G
IIa Yes 46741
29 June 2018
3.2 mm UniBevel Clear Corneal Knife Angled 52-3242
IIa Yes 46741
29 June 2018
3.2 mm UniBevel Clear Corneal Knife, Angled, Guarded 52-3242-G
IIa Yes 46741
29 June 2018
#57 Scleral Knife 58-5703
IIa Yes 46741
29 June 2018
Lamellar Knife 58-6603
IIa Yes 46741
29 June 2018
Needle Knife 58-6810
IIa Yes 46741
29 June 2018
#69 Knife 58-6903
IIa Yes 46741
29 June 2018
3.0 mm Slit Blade, Straight, Flatstock 52-2902F
IIa Yes 46741
29 June 2018
#57 Blade 58-5700
IIa Yes 46741
29 June 2018
#64 Blade 58-6400
IIa Yes 46741
29 June 2018
MDD – Product List
Product List for Certificate No: 41377486-01 Date: 09 March 2019
Page 14 of 19
Intertek Semko AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden
Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www.intertek.se Registered in Sweden: No SE556024059901, Registered office: As address
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Product category Type/Model designation
Class Sterile GMDN code
(not mandatory)
Date added
#66 Blade 58-6600
IIa Yes 46741
29 June 2018
#67 Blade 58-6700
IIa Yes 46741
29 June 2018
#69 Blade 58-6900
IIa Yes 46741
29 June 2018
15 Deg. Stab Blade & Threaded Tip 52-1502
IIa Yes 37445 29 June 2018
15 Deg. Stab Blade & Threaded Tip (bulk) 52-1502-NS
IIa Yes 37445 29 June 2018
15 Deg. 3 mm Restricted Depth Stab Blade & Threaded Tip 52-1532
IIa Yes 37445 29 June 2018
15 Deg. 5 mm Restricted Depth Stab Blade & Threaded Tip 52-1552
IIa Yes 37445 29 June 2018
22.5 Deg. Stab Blade & Threaded Tip 52-2202
IIa Yes 37445 29 June 2018
2.65 mm Slit Blade & Threaded Tip Angled 52-2662
IIa Yes 37445 29 June 2018
2.75 mm Slit Blade & Threaded Tip Angled 52-2762
IIa Yes 37445 29 June 2018
2.85 mm Slit Blade & Threaded Tip Angled 52-2862
IIa Yes 37445 29 June 2018
3.0 mm Slit Blade & Threaded Tip Angled 52-2962
IIa Yes 37445 29 June 2018
30 Deg. Stab Blade & Threaded Tip 52-3002
IIa Yes 37445 29 June 2018
3.2 mm Slit Blade & Threaded Tip Angled 52-3262
IIa Yes 37445 29 June 2018
Crescent Blade & Threaded Tip Straight 54-5000
IIa Yes 37445 29 June 2018
Crescent Blade & Threaded Tip Angled 54-5062
IIa Yes 37445 29 June 2018
#57 Blade & Threaded Tip 58-5702
IIa Yes 37445 29 June 2018
MDD – Product List
Product List for Certificate No: 41377486-01 Date: 09 March 2019
Page 15 of 19
Intertek Semko AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden
Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www.intertek.se Registered in Sweden: No SE556024059901, Registered office: As address
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Product category Type/Model designation
Class Sterile GMDN code
(not mandatory)
Date added
6600 Lamellar Blade & Threaded Tip Angled 58-6602
IIa Yes 37445 29 June 2018
#69 Blade & Threaded Tip 58-6902
IIa Yes 37445 29 June 2018
2.65 mm Clear Corneal, Angled 62-2663
IIa Yes 46741 29 June 2018
2.0 mm Crescent Knife Angled 64-1010
IIa Yes 46741 29 June 2018
2.2 mm CMP Knife Angled, Dual Bevel 62-2263
IIa Yes 46741 29 June 2018
1.8 mm MicroPhaco Slit Knife Angled 62-1863
IIa Yes 46741 29 June 2018
2.0 mm MicroPhaco Slit Knife Angled 62-2063
IIa Yes 46741 29 June 2018
2.2 mm MicroPhaco Slit Knife Angled 62-2261
IIa Yes 46741 29 June 2018
2.4 mm Slit Knife Angled 62-2461
IIa Yes 46741 29 June 2018
2.5 mm Slit Knife Angled 62-2561
IIa Yes 46741 29 June 2018
2.75 mm Slit Knife Angled 62-2761
IIa Yes 46741 29 June 2018
2.85 mm Slit Knife Angled 62-2861
IIa Yes 46741 29 June 2018
3.0 mm Slit Knife Angled 62-2961
IIa Yes 46741 29 June 2018
3.2 mm Slit Knife Angled 62-3261
IIa Yes 46741 29 June 2018
1.0 mm Sideport MVR Style Knife Angled 68-2010
IIa Yes 46741 29 June 2018
1.2 mm Sideport MVR Style Knife Angled 68-2012
IIa Yes 46741 29 June 2018
15 Deg. Stab Knife 62-1501
IIa Yes 46741 29 June 2018
30 Deg. Stab Knife 62-3001
IIa Yes 46741 29 June 2018
MDD – Product List
Product List for Certificate No: 41377486-01 Date: 09 March 2019
Page 16 of 19
Intertek Semko AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden
Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www.intertek.se Registered in Sweden: No SE556024059901, Registered office: As address
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Product category Type/Model designation
Class Sterile GMDN code
(not mandatory)
Date added
45 Deg. Stab Knife 62-4501
IIa Yes 46741 29 June 2018
1.5mm x 2.0mm Trapezoid, Angled 65-1520
IIa Yes 46741 29 June 2018
1.8mm x 2.2mm Trapezoid, Angled 65-1822
IIa Yes 46741 29 June 2018
20 Gauge Vitrectomy Knife, Straight 61-2001
IIa Yes 46741 29 June 2018
1.4 mm MicroPhaco Slit Knife Angled EDGE4-1.4
IIa Yes 46741 29 June 2018
1.8mm MicroPhaco Slit Knife Angled
EDGE4-1.8
IIa Yes 46741 10 Jan 2019
2.0 mm MicroPhaco Slit Knife Angled EDGE4-2.0
IIa Yes 46741 29 June 2018
2.2 mm MicroPhaco Slit Knife Angled EDGE4-2.2
IIa Yes 46741 29 June 2018
2.4mm Slit Knife Angled EDGE-2.4A
IIa Yes 46741 10 Jan 2019
2.5 mm Slit Knife Angled EDGE-2.5A
IIa Yes 46741 29 June 2018
2.65 mm Slit Knife Angled EDGE-2.65A
IIa Yes 46741 29 June 2018
2.75 mm Slit Knife Angled EDGE-2.75A
IIa Yes 46741 29 June 2018
2.75 mm Slit Knife Angled, Guarded EDGEG-2.75A
IIa Yes 46741 29 June 2018
2.8 mm Slit Knife Angled, Double Bevel EDGE-2.8DB
IIa Yes 46741 29 June 2018
2.85 mm Slit Knife Angled EDGE-2.85A
IIa Yes 46741 29 June 2018
3.0 mm Slit Knife Angled EDGE-3.0A
IIa Yes 46741 29 June 2018
3.2 mm Slit Knife Angled EDGE-3.2A
IIa Yes 46741 29 June 2018
MDD – Product List
Product List for Certificate No: 41377486-01 Date: 09 March 2019
Page 17 of 19
Intertek Semko AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden
Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www.intertek.se Registered in Sweden: No SE556024059901, Registered office: As address
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Product category Type/Model designation
Class Sterile GMDN code
(not mandatory)
Date added
5.2 mm Slit Knife Angled EDGE-5.2A
IIa Yes 46741 29 June 2018
15 Deg. Stab Knife EDGE-15DEG
IIa Yes 46741 29 June 2018
30 Deg. Stab Knife EDGE1-30DEG
IIa Yes 46741 29 June 2018
45 Deg. Stab Knife EDGE1-45DEG
IIa Yes 46741 29 June 2018
2.0 mm Crescent Knife, Straight EDGE5-2.0S
IIa Yes 46741 29 June 2018
2.0 mm Crescent Knife Angled EDGE5-2.0A
IIa Yes 46741 29 June 2018
2.3 mm Crescent Knife Angled EDGE5-2.3
IIa Yes 46741 10 Jan 2019
4.0 mm Implant Knife Angled EDGE7-4.0
IIa Yes 46741 29 June 2018
0.8 mm (23G) MVR Sideport Knife, Angled EDGE9-0.8A
IIa Yes 46741 29 June 2018
1.0 mm MVR Sideport Knife Angled EDGE-1.00A
IIa Yes 46741 29 June 2018
1.2 mm (20G) MVR Sideport Knife, Angled EDGE9-1.2A
IIa Yes 46741 29 June 2018
1.4 mm (19G) MVR Sideport Knife, Angled EDGE9-1.4A
IIa Yes 46741 29 June 2018
20 Gauge Vitrectomy Knife, Straight EDGE8-20GS
IIa Yes 46741 29 June 2018
1.2 mm MicroPhaco Slit Knife Angled F52-1263
IIa Yes 46741 29 June 2018
1.4 mm MicroPhaco Slit Knife Angled F52-1463
IIa Yes 46741 29 June 2018
1.8 mm MicroPhaco Slit Knife, Angled F52-1863
IIa Yes 46741 29 June 2018
2.2 mm MicroPhaco Slit Knife Angled F52-2261
IIa Yes 46741 29 June 2018
2.2 mm CMP Knife, Angled, Double Bevel F52-2263
IIa Yes 46741 29 June 2018
MDD – Product List
Product List for Certificate No: 41377486-01 Date: 09 March 2019
Page 18 of 19
Intertek Semko AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden
Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www.intertek.se Registered in Sweden: No SE556024059901, Registered office: As address
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Product category Type/Model designation
Class Sterile GMDN code
(not mandatory)
Date added
2.4 mm Slit Knife, Angled, Double Bevel F52-2431
IIa Yes 46741 29 June 2018
2.4 mm Slit Knife Angled F52-2461
IIa Yes 46741 29 June 2018
2.75 mm Slit Knife Angled F52-2761
IIa Yes 46741 29 June 2018
2.85 mm Slit Knife Angled F52-2861
IIa Yes 46741 29 June 2018
3.0 mm Slit Knife Angled F52-2961
IIa Yes 46741 29 June 2018
3.2 mm Slit Knife Angled F52-3261
IIa Yes 46741 29 June 2018
5.2 mm Slit Knife Angled F52-F5261
IIa Yes 46741 29 June 2018
2.75 mm Clear Corneal Knife Angled F52-2763
IIa Yes 46741 29 June 2018
15 Deg. Stab Knife F52-1501
IIa Yes 46741 29 June 2018
15 Deg. 5mm Restricted Depth Stab Knife F52-1551
IIa Yes 46741 29 June 2018
22.5 Deg Stab Knife F52-2201
IIa Yes 46741 29 June 2018
30 Deg Stab Knife F52-3001
IIa Yes 46741 29 June 2018
2.0 mm Crescent Knife Angled F54-1010
IIa Yes 46741 29 June 2018
1.0 mm MVR Sideport Knife Angled F58-2010
IIa Yes 46741 29 June 2018
20 Gauge Vitrectomy Knife, Straight F51-2001
IIa Yes 46741 29 June 2018
2.75 mm UniBevel Slit Knife Angled F52-2740
IIa Yes 46741 29 June 2018
