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Consultation procedure for a medicinal substance added to a medical device Notified body decision

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Consultation procedure for a medicinal substance added to a medical device

Notified body decision

1. Name of product 2. Consultation reference number(Insert number

allocated by ANSM)

           

3. Notified Body

(insert name, address, telephone and e-mail address of contact person)

4. Applicant seeking device approval (insert name and address)

           

5. Decision of notified body

 The EC certificate was issued

 The EC certificate was not issued (Please comment as appropriate)

Signature Date Capacity in which signed:

Please complete all boxes and return form to:

ANSM

DMCDIV – dmcdiv@ansm.sante.fr

Consultation procedure for a medicinal substance added to a Medical Device 143/147 bd Anatole France

F-93285 Saint-Denis cedex - France

July 2021

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