Identity
- Trade Name
- UCP Stem EUDAMEDUTF™ Stem FDA UDI
- Generic Name
- Femoral stem prosthesis trial FDA UDI
- Device Name
- UCP Neck trial, standard EUDAMEDFDA UDI
- Model / Reference
- 9107-5110 EUDAMEDFDA UDI
- Description
- UCP Neck trial, standard FDA UDI
Identifiers
- Catalog Number
- 9107-5110 FDA UDI
- Primary DI / UDI-DI
- 04719872171287 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04719872171287 EUDAMED
- 510(k) Number
- K152530 FDA UDI
- FDA Product Code
- LWJ FDA UDIJDI FDA UDILZO FDA UDIKWY FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Femoral stem prosthesis trial FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3360 FDA UDI888.3350 FDA UDI888.3353 FDA UDI888.3390 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
UCP Stem by United Orthopedic Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04719872171287 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- United Orthopedic Corporation
- EUDAMED SRN
- TW-MF-000009523
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 21a4322a-b256-4557-93b5-780535f264f6 61 fields · synced Jul 10, 2026
- FDA UDI b8b8115b-6f70-4c6c-9049-74247767d3b4 37 fields · synced May 30, 2026