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S-Rom Noiles
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 63-4238Model S-ROM NOILES Patella Trial
Identity
- Trade Name
- S-ROM NOILES EUDAMEDS-ROM NOILES FDA UDI
- Generic Name
- Patella prosthesis trial FDA UDI
- Device Name
- Patella Trial EUDAMEDS-ROM NOILES PATELLAR TRIAL 38mm FDA UDI
- Model / Reference
- S-ROM NOILES Patella Trial EUDAMED63-4238 EUDAMEDFDA UDI
- Description
- S-ROM NOILES PATELLAR TRIAL 38mm FDA UDI
Identifiers
- Catalog Number
- 634238 FDA UDI
- Primary DI / UDI-DI
- 10603295181750 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a001478M EUDAMED
- Direct Marketing DI
- 10603295181750 EUDAMED
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Patella 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
S-Rom Noiles 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 | 0603295a001478M | 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 1ed68a4e-c708-4e83-a027-f3fee3a46d16 61 fields · synced May 30, 2026
- FDA UDI 6d2a3407-84cd-4c81-9e80-9273adcea2cc 35 fields · synced May 30, 2026