U2 Total Knee System Tibial Augment, MBA, #1, 5mm Thick
- Risk class
- Class IIb
- CND nomenclatures code
- P09098001
- Trade name
- U2 Total Knee System
- Implantable
- Yes
- Reusable
- No
- Measuring function
- No
- Primary DI
- 04719872178613
- Basic UDI
- B-04719872178613
- Version date
- December 31, 2024
- Manufacturer last update
- September 18, 2024
- Active status
- No
- Manufacturer name
- United Orthopedic Corporation
- Country
- Taiwan
- Country type
- NON_EU
- Address
- No. 16 Luke 1st Rd., Luzhu Dist., Kaohsiung City, Taiwan 82151 Kaohsiung
- regulatory@Unitedorthopedic.com
- Name
- mdi Europa GmbH
- SRN
- DE-AR-000006218
- Country
- Germany
- Address
- 71 Langenhagener Straße Langenhagen
- info@mdi-europa.com
- Competent authority
- DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
- Applicable legislation
- MDD (Directive 93/42/EEC on Medical Devices)
- Placed on the market
- France
- Market available
- France:None~None
- Human tissues
- No
- Animal tissues
- No
KNEE PROSTHESES AUGMENTS
Access comprehensive regulatory information for U2 Total Knee System Tibial Augment, MBA, #1, 5mm Thick in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 04719872178613 and manufactured by United Orthopedic Corporation in Taiwan.
This page provides complete registration details including trade name (U2 Total Knee System), manufacturer information, authorized representative details, competent authority (DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover), 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.