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United Hip and Knee Non-sterile Reusable Instruments - EUDAMED Registration 04719872179054

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.

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EUDAMED Official Data
Class I
04719872179054
No
United Hip and Knee Non-sterile Reusable Instruments
Trade Name: U1 Total Hip System
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Device Description (EMDN)

ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
L091199
Trade Name
U1 Total Hip System
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
04719872179054
Basic UDI
471987216TD-Ir-003F4
Version Date
February 18, 2025
Manufacturer Last Update
September 18, 2024
Active Status
No
Manufacturer
Country
Taiwan
Country Type
NON_EU
Address
No. 16 Luke 1st Rd., Luzhu Dist., Kaohsiung City, Taiwan 82151 Kaohsiung
Email
regulatory@Unitedorthopedic.com
Authorized Representative
SRN
DE-AR-000006218
Country
Germany
Address
71 Langenhagener StraรŸe Langenhagen
Email
info@mdi-europa.com
Regulatory Information
Competent Authority
DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
France
Device Characteristics
Human Tissues
No
Animal Tissues
No