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Self Centering
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2055-43-000Model SELF CENTERING Self-Centering Modular Liner Trial
Identity
- Trade Name
- SELF CENTERING EUDAMEDFDA UDI
- Generic Name
- Femoral head prosthesis trial FDA UDI
- Device Name
- Self-Centering Modular Liner Trial EUDAMEDSELF CENTERING MODULAR CATHCART MOD HEMI HIP HEAD TRIAL 43OD x 28ID FDA UDI
- Model / Reference
- SELF CENTERING Self-Centering Modular Liner Trial EUDAMED2055-43-000 EUDAMEDFDA UDI
- Description
- SELF CENTERING MODULAR CATHCART MOD HEMI HIP HEAD TRIAL 43OD x 28ID FDA UDI
Identifiers
- Catalog Number
- 205543000 FDA UDI
- Primary DI / UDI-DI
- 10603295084600 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a0013084 EUDAMED
- Direct Marketing DI
- 10603295084600 EUDAMED
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Femoral head prosthesis trial FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Self Centering by DePuy Ireland UC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0603295a0013084 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED 5c799bc2-f350-4de7-a9ac-0f2939929192 61 fields · synced Jun 19, 2026
- FDA UDI d4626a4d-4e90-45ff-9a2a-1e396805a229 35 fields · synced May 30, 2026