EUDAMED registration 00180668000243NoImplantation Instrument Set- INTL
- Risk class
- Class I
- CND nomenclatures code
- L99
- Trade name
- Uromedica ACT/ProACT Implantation Instrument Set
- Implantable
- No
- Reusable
- Yes
- Measuring function
- No
- Primary DI
- 00180668000243
- Basic UDI
- B-00180668000243
- Version date
- May 13, 2024
- Manufacturer last update
- June 16, 2023
- Active status
- No
- Manufacturer name
- Uromedica, Incorporated
- Country
- United States
- Country type
- NON_EU
- Address
- 1840 Berkshire Lane N Plymouth
- info@uromedica-inc.com
- Name
- MEDIMARK EUROPE
- SRN
- FR-AR-000000182
- Country
- France
- Address
- 11 RUE EMILE ZOLA BP 2332 GRENOBLE cedex 2
- info@medimark-europe.com
- Telephone
- +33 4 76 86 43 22
- Competent authority
- Agence Nationale de Sécurité du Médicament et des Produits de Santé
- Applicable legislation
- MDD (Directive 93/42/EEC on Medical Devices)
- Placed on the market
- France
- Human tissues
- No
- Animal tissues
- No
SURGICAL INSTRUMENTS, REUSABLE - OTHER
Access comprehensive regulatory information for Implantation Instrument Set- INTL 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 00180668000243 and manufactured by Uromedica, Incorporated in United States.
This page provides complete registration details including trade name (Uromedica ACT/ProACT Implantation Instrument Set), manufacturer information, authorized representative details, 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.