Regulatory / Quality Assurance

Manufacturers of medical devices based outside the EU must designate
an Authorized Representative (EC-REP) established within the EU in order to meet
the CE requirements for placing medical devices on the EU market.

European Authorized Representative


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Manufacturers of medical devices based outside the EU must designate an Authorized Representative (EC-REP) established within the EU in order to meet the CE requirements for placing medical devices on the EU market.

Les fabricants de dispositifs médicaux basés en dehors de l’Union Européenne doivent dorénavant désigner un Représentant du marquage CE (EC-REP en anglais). Ce dernier doit être localisé au sein de l’Union Européenne afin de répondre aux exigences CE pour la mise à disposition d’un dispositif médical sur le territoire européen.

Authorized representative:

Regen Lab France S.A.S

Address:

2 Avenue de Laponie, 91940 Les Ulis, France

Contact person / e-mail:

Office manager: Béatrice Montel, France@regenlab.com
Person Responsible for Regulatory Compliance (PRRC):
Franck Martin, franck@expereg.com
Complaints: PMS@regenlab.com

Phone:

+33 1 42 00 22 90

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MANUFACTURER

Legal Manufacturer

REGEN LAB SA

Address

En Budron B2
1052 Le Mont-sur-Lausanne
Switzerland (CH)

Extension (storage area)

En Budron C5
1052 Le Mont-sur-Lausanne
Switzerland (CH)

Phone

+41 (0) 21 864 01 11

Fax

+41 (0) 21 864 01 10

Contact Regenlab

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