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U1 Hip System Femoral Head, 26mm Dia., +0mm Neck Length - EUDAMED Registration 04712602341424

Access comprehensive regulatory information for U1 Hip System Femoral Head, 26mm Dia., +0mm Neck Length in the European Union medical device market through Pure Global AI's free database. This Class III device is registered with EU EUDAMED under Primary DI 04712602341424 and manufactured by United Orthopedic Corporation in Taiwan.

This page provides complete registration details including 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 III
04712602341424
No
U1 Hip System Femoral Head, 26mm Dia., +0mm Neck Length
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

METAL FEMORAL HEADS, PARTIAL HIP REPLACEMENT

Device Classification
Risk Class
Class III
CND Nomenclatures Code
P090804050102
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
04712602341424
Basic UDI
B-04712602341424
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
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
France
Market Available
France:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No