EC Certificate - Full Qualit Assurance S stem

S I CE 685187

Issued To: MJN N SLA . J C I , 184 B (G )17300S

First Issued: 2020-04-29 Date: 2020-04-29 Expir Date: 2024-05-26

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Validit of this certificate is conditional on the qualit s stem being maintained to the requirements of the Directive as demonstrated through the requiredsurveillance activities of the Notified Bod . This approval excludes all products designed and/or manufactured b a third part on behalf of the compannamed on this certificate, unless specificall agreed with BSI.This certificate was issued electronicall and is bound b the conditions of the contract.

Information and Contact: BSI, Sa Building, John M. Ke nesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.A member of BSI Group of Companies.

EC Certificate - Full Qualit Assurance S stemDirective 93/42/EEC on Medical Devices, Annex I I excluding Section 4

N . CE 685187Issued To: MJN N SL

A . J C I , 184 B (G )17300S

In respect of:

D

on the basis of our examination of the qualit assurance s stem under the requirements of Council Directive93/42/EEC, Annex I I excluding section 4. The qualit assurance s stem meets the requirements of the directive. Forthe placing on the market of class II I products an Annex I I section 4 certificate is required.

For and on behalf of BSI, a Notified Bod for the above Directive (Notified Bod Number 2797):

Gar E Slack, Senior Vice President Medical Devices

First Issued: 2020-04-29 Date: 2020-04-29 Expir Date: 2024-05-26

Page 1 of 2

Validit of this certificate is conditional on the qualit s stem being maintained to the requirements of the Directive as demonstrated through the requiredsurveillance activities of the Notified Bod . This approval excludes all products designed and/or manufactured b a third part on behalf of the compannamed on this certificate, unless specificall agreed with BSI.This certificate was issued electronicall and is bound b the conditions of the contract.

Information and Contact: BSI, Sa Building, John M. Ke nesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.A member of BSI Group of Companies.