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August-Schanz-Straße 21, 60433 Frankfurt am Main, Tel. +49 (0) 69 95427-300, [email protected] 1 / 3 410.90.en Version 1.0 CERTIFICATE This is to certify that the company 3M Deutschland GmbH trading as „Health Care Business“ Carl-Schurz-Str. 1 41453 Neuss Germany with the organizational units/sites as listed in the annex has implemented and maintains a Quality Management System. Scope: The design, development, manufacture, sales & marketing and distribution of skin protection products, casting products, drapes, gowns, wound dressings and films, surgical masks, patient warming/cooling blankets, accessories for electrosurgical equipment, sterilization indicators, sterilization indicator systems, sterilization packaging materials, tapes and eye patches including silicone technology, wraps and bandages. Manufacture of transparent films for wound dressings including silicone technology. Design and development, manufacture and distribution of orthodontic devices. Customer Service, Warehousing and Distribution of Orthodontic Products. Through an audit, documented in a report, performed by DQS Medizinprodukte GmbH, it was verified that the management system fulfills the requirements of the following standard: DIN EN ISO 13485 : 2016 + AC : 2017-07 EN ISO 13485 : 2016 + AC : 2016 ISO 13485 : 2016 Certificate registration no. Certificate unique ID Effective date Expiry date Frankfurt am Main 003626 MP2016 170729542 2019-03-08 2020-03-16 2019-03-08 DQS Medizinprodukte GmbH Sigrid Uhlemann Managing Director Dr. Thomas Feldmann Head of Certification Body

MP2016 003626 MP2016 ENmultimedia.3m.com/mws/media/951072O/zertifikat-iso-13485.pdf · 2019-08-15 · ISO 13485 : 2016 Certificate registration no. Certificate unique ID Effective

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Page 1: MP2016 003626 MP2016 ENmultimedia.3m.com/mws/media/951072O/zertifikat-iso-13485.pdf · 2019-08-15 · ISO 13485 : 2016 Certificate registration no. Certificate unique ID Effective

August-Schanz-Straße 21, 60433 Frankfurt am Main, Tel. +49 (0) 69 95427-300, [email protected] 1 / 3

410.

90.e

n V

ersi

on 1

.0

CERTIFICATE

This is to certify that the company

3M Deutschland GmbH trading as „Health Care Business“

Carl-Schurz-Str. 1 41453 Neuss Germany with the organizational units/sites as listed in the annex

has implemented and maintains a Quality Management System.

Scope: The design, development, manufacture, sales & marketing and distribution of skin protection products, casting products, drapes, gowns, wound dressings and films, surgical masks, patient warming/cooling blankets, accessories for electrosurgical equipment, sterilization indicators, sterilization indicator systems, sterilization packaging materials, tapes and eye patches including silicone technology, wraps and bandages. Manufacture of transparent films for wound dressings including silicone technology. Design and development, manufacture and distribution of orthodontic devices. Customer Service, Warehousing and Distribution of Orthodontic Products.

Through an audit, documented in a report, performed by DQS Medizinprodukte GmbH, it was verified that the management system fulfills the requirements of the following standard:

DIN EN ISO 13485 : 2016 + AC : 2017-07 EN ISO 13485 : 2016 + AC : 2016 ISO 13485 : 2016

Certificate registration no.

Certificate unique ID

Effective date

Expiry date

Frankfurt am Main

003626 MP2016

170729542

2019-03-08

2020-03-16

2019-03-08

DQS Medizinprodukte GmbH

Sigrid Uhlemann Managing Director

Dr. Thomas Feldmann Head of Certification Body

Page 2: MP2016 003626 MP2016 ENmultimedia.3m.com/mws/media/951072O/zertifikat-iso-13485.pdf · 2019-08-15 · ISO 13485 : 2016 Certificate registration no. Certificate unique ID Effective

Annex to certificate Certificate registration No.: 003626 MP2016 Certificate unique ID: 170729542 Effective date: 2019-03-08 3M Deutschland GmbH trading as „Health Care Business“

Carl-Schurz-Str. 1 41453 Neuss Germany

This annex is only valid in connection with the above-mentioned certificate. 2 / 3

Location Scope

3M Deutschland GmbH Health Care Business Carl-Schurz-Str. 1 41453 Neuss Germany

The design, development, manufacture, sales & marketing and distribution of skin protection products, casting products, drapes, gowns, wound dressings and films including silicone technology, surgical masks, patient warming/cooling blankets, accessories for electrosurgical equipment, sterilization indicator systems, sterilization packaging materials, tapes and eye pachtes including silicone technology , wraps and bandages.

3M Deutschland GmbH Health Care Business Entwicklung Carl-Schurz-Straße 1 41453 Neuss Germany

The design, development of skin protection products, casting products, drapes, gowns, wound dressings and films including silicone technology, surgical masks, patient warming/cooling blankets, accessories for electrosurgical equipment, sterilization indicator systems, sterilization packaging materials, tapes and eye patches including silicone technology, wraps and bandages.

TOP-Service für Lingualtechnik GmbH Schledehauser Straße 81 49152 Bad Essen Germany

Design and development, manufacture and distribution of orthodontic devices.

3M Deutschland GmbH Health Care Business Plant Kamen Edisonstraße 6 59174 Kamen Germany

The manufacture of transparent films for wound dressings, tapes and eye patches including silicone technlogy, wraps, bandages and patient warming/cooling blankets.

Page 3: MP2016 003626 MP2016 ENmultimedia.3m.com/mws/media/951072O/zertifikat-iso-13485.pdf · 2019-08-15 · ISO 13485 : 2016 Certificate registration no. Certificate unique ID Effective

Annex to certificate Certificate registration No.: 003626 MP2016 Certificate unique ID: 170729542 Effective date: 2019-03-08 3M Deutschland GmbH trading as „Health Care Business“

Carl-Schurz-Str. 1 41453 Neuss Germany

This annex is only valid in connection with the above-mentioned certificate. 3 / 3

Location Scope

3M Deutschland GmbH Health Care Business European Distribution Center Ohmstrasse 3 86899 Landsberg Germany

Customer Service, Warehousing and Distribution of Orthodontics Products