Class I Instrument
- Risk class
- Class I
- CND nomenclatures code
- L0999
- Trade name
- ENCLUME ASSEMBLAGE ARAMIS
- Implantable
- No
- Reusable
- Yes
- Measuring function
- No
- Primary DI
- M483EAAEA000
- Basic UDI
- ++M483L0999ZW
- Active status
- No
- Manufacturer name
- groupe lépine
- Country
- France
- Country type
- EU_MEMBER_STATE
- Address
- 175 rue Jacquard Genay Cedex
- l.fiscus@groupe-lepine.com
- 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
- Human tissues
- No
- Animal tissues
- No
ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER
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.