ec certificate - full qualit assurance sstemec certificate - full qualit assurance sstem si ce685187...

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EC Certificate - Full Qualit Assurance S stem S I CE 685187 Issued To: MJN N SL A . J C I, 184 B (G ) 17300 S 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 required surveillance activities of the Notified Bod . This approval excludes all products designed and/or manufactured b a third part on behalf of the compan named 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 0780 BSI Group The Netherlands B.V. registered in The Netherlands under 33264284. A member of BSI Group of Companies. EC Certificate - Full Qualit Assurance S stem Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4 N . CE 685187 Issued To: MJN N SL A . J C I, 184 B (G ) 17300 S In respect of: D on the basis of our examination of the qualit assurance s stem under the requirements of Council Directive 93/42/EEC, Annex II excluding section 4. The qualit assurance s stem meets the requirements of the directive. For the placing on the market of class III products an Annex II 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 required surveillance activities of the Notified Bod . This approval excludes all products designed and/or manufactured b a third part on behalf of the compan named 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 0780 BSI Group The Netherlands B.V. registered in The Netherlands under 33264284. A member of BSI Group of Companies.

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Page 1: EC Certificate - Full Qualit Assurance SstemEC Certificate - Full Qualit Assurance Sstem SI CE685187 IssuedTo: MJNNSL A.JCI,184 B(G) 17300 S First sued:2020-04-29Date:2020-04-29ExpirDate:2024-05-26

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

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.

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.