United Hip and Knee Non-sterile Reusable Instruments
- Risk class
- Class I
- CND nomenclatures code
- L091199
- Trade name
- U1 Total Hip System
- Implantable
- No
- Reusable
- Yes
- Measuring function
- No
- Primary DI
- 04719872179054
- Basic UDI
- 471987216TD-Ir-003F4
- Version date
- February 18, 2025
- 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
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- France
- Human tissues
- No
- Animal tissues
- No
ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER
Access comprehensive regulatory information for United Hip and Knee Non-sterile Reusable Instruments 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 04719872179054 and manufactured by United Orthopedic Corporation in Taiwan.
This page provides complete registration details including trade name (U1 Total Hip 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.