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Class I Instrument - EUDAMED Registration M483EAAEA000

Access comprehensive regulatory information for Class I Instrument in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI M483EAAEA000 and manufactured by groupe lépine in France.

This page provides complete registration details including trade name (ENCLUME ASSEMBLAGE ARAMIS), manufacturer information, competent authority (Agence Nationale de Sécurité du Médicament et des Produits de Santé), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

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EUDAMED Official Data
Class I
M483EAAEA000
No
Class I Instrument
Trade Name: ENCLUME ASSEMBLAGE ARAMIS
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Device Description (EMDN)

ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
L0999
Trade Name
ENCLUME ASSEMBLAGE ARAMIS
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
M483EAAEA000
Basic UDI
++M483L0999ZW
Active Status
No
Manufacturer
Manufacturer Name
groupe lépine
Country
France
Country Type
EU_MEMBER_STATE
Address
175 rue Jacquard Genay Cedex
Email
l.fiscus@groupe-lepine.com
Regulatory Information
Competent Authority
Agence Nationale de Sécurité du Médicament et des Produits de Santé
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
France
Device Characteristics
Human Tissues
No
Animal Tissues
No