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Corail Amt
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref L94004Model CORAIL AMT Hip Neck Femoral Trial Prosthesis
Identity
- Trade Name
- CORAIL AMT EUDAMEDCORAIL FDA UDI
- Generic Name
- Femoral stem prosthesis trial FDA UDI
- Device Name
- Hip Neck Femoral Trial Prosthesis EUDAMEDCORAIL AMT NECK SEGMENT 125 DEGREE KLA FDA UDI
- Model / Reference
- CORAIL AMT Hip Neck Femoral Trial Prosthesis EUDAMEDL94004 EUDAMEDFDA UDI
- Description
- CORAIL AMT NECK SEGMENT 125 DEGREE KLA FDA UDI
Identifiers
- Catalog Number
- L94004 FDA UDI
- Primary DI / UDI-DI
- 10603295325154 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a000728F EUDAMED
- Direct Marketing DI
- 10603295325154 EUDAMED
- FDA Product Code
- LXH 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 I FDA UDI
- Regulation Number
- 888.4540 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
Yes
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
Corail Amt 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 | 0603295a000728F | 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 06b69280-c1a3-4551-98ab-bfe3eb69557b 61 fields · synced Jun 19, 2026
- FDA UDI c83925f2-a331-4b4b-90c8-785b107726df 35 fields · synced May 30, 2026