CERTIFICATEThis is to certify that the Quality Management System of

MEDCU TECHNOLOGIES LTD.10 H'asadnaot St. , Herzeliya , Israel

Has been assessed and complies with the requirements of :

ISO 13485:2016This Certificate is Applicable to

Development, manufacturing and sale of wound dressing products.

Certificate No.: 98889 Certificate Issue Date: 29/11/2018Initial Certification Date: 29/11/2018 Certification Expiry Date: 28/11/2021

SII-QCD assumes no liability to any party other than the client, and then only in accordance with the agreed upon Certification Agreement.This certificate’s validity is subject to the organization maintaining their system in accordance with SII-QCD requirements for system certification. Thecontinued validity may be verified via scanning the code with a smartphone, or via website www.sii.org.il. This certificate remains the property of SII-QCD.

Ilan CarmitActing Director General R.N 515528990

Avital WeinbergDirector, Quality & Certification Division

Page 1 of 1 Our Vision: To Enhance Both Global Competitiveness of our Services, with our Uncompromised Quality and Integrity

תעודהשלמערכת ניהול האיכותוזאת לתעודה כי

מדקיו טכנולוגיות בע"מישראל,הרצליה,הסדנאות 10

‘

:התקןתלדרישומתאימהנבחנה ונסקרה ע"י מכון התקנים הישראלי-אגף איכות והסמכה ונמצאה

ת"י 13485:2016האישור תקף ל:

פיתוח, יצור ושיווק של מוצרי חבישה.

29/11/2018:הוצאהתאריך98889מס' אישור:28/11/2021האישור בתוקף עד:29/11/2018:אישור ראשוני

תוקף התעודה כפוף לכך שהארגון ימשיך לנהוג בהתאם לדרישות המכון להתעדה.בהתאם לאמור בהסכם ההתעדה.הכלאינו מקבל על עצמו אחריות כלפי צד כלשהו, למעט הלקוח בעל תעודה זו,מת"י

www.sii.org.ilאיכות והסמכה. לברור תקפות – סרוק באמצעות טלפון חכם את הברקוד, או באמצעות האתר-אגףמת"יהתעודה היא רכוש

אילן כרמית515528990ח.פמ"מ מנכ"ל

אביטל ויינברגראש אגף איכות והסמכה

1מתוך1עמוד

CERTIFICATETHE STANDARDS INSTITUTION OF ISRAEL AS AN IQNET PARTNER

Hereby certify that the organization

MEDCU TECHNOLOGIES LTD.10 H'asadnaot St., Herzeliya, Israel

For the following scope:

Development, manufacturing and sale of wound dressing products.

Has implemented and maintains a Quality Management Systemwhich fulfils the requirement of the following standard:

ISO 13485:2016

Issued on: 29/11/2018Date of expiration: 28/11/2021Date of initial approval: 29/11/2018

Registration number: IL - 98889

Alex StoichitoiuPresident of IQNet

Ilan CarmitActing Director General

IQNet Partners**:AENOR Spain AFNOR Certification France APCER Portugal CCC Cyprus CISQ Italy

CQC China CQM China CQS Czech Republic Cro Cert Croatia DQS Holding GmbH Germany FCAV BrazilFONDONORMA Venezuela ICONTEC Colombia Inspecta Certification Finland INTECO Costa Rica

IRAM Argentina JQA Japan KFQ Korea MIRTEC Greece MSZT Hungary Nemko AS Norway NSAI Ireland PCBC PolandQuality Austria Austria RR Russia SIGE México SII Israel SIQ Slovenia SIRIM QAS International MalaysiaSQS Switzerland SRAC Romania TEST St Petersburg Russia TSE Turkey Vinçotte Belgium YUQS Serbia

IQNet is represented in the USA by: AFNOR Certification, CISQ, DQS Holding GmbH and NSAI Inc.

* This attestation is directly linked to the IQNet Partner’s original certificate and shall not be used as a stand-alone document

** The list of IQNet partners is valid at the time of issue of this certificate. Updated information is available under www.iqnet-certification.com

www.sii.org.il