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S-Rom Noiles
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 62-3685Model SROM NRH Bearing, Bumper, and Hinge Pin
Identity
- Trade Name
- S-ROM NOILES EUDAMEDS-ROM NOILES FDA UDI
- Generic Name
- Rotating hinged total knee prosthesis FDA UDI
- Device Name
- Bearing, Bumper, and Hinge Pin EUDAMEDS-ROM NOILES ROTATING HINGE KNEE BUMPER MEDIUM FDA UDI
- Model / Reference
- SROM NRH Bearing, Bumper, and Hinge Pin EUDAMED62-3685 EUDAMEDFDA UDI
- Description
- S-ROM NOILES ROTATING HINGE KNEE BUMPER MEDIUM FDA UDI
Identifiers
- Catalog Number
- 623685 FDA UDI
- Primary DI / UDI-DI
- 10603295179535 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a004448W EUDAMED
- FDA Product Code
- JWH FDA UDI
- EMDN Code
- P09098099 KNEE PROSTHESES - ACCESSORIES - OTHER EUDAMED
- GMDN Term
- Rotating hinged total knee prosthesis FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
S-Rom Noiles by DePuy Ireland UC — Class IIb — CE/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 | 0603295a004448W | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED e34bfd79-88e2-4825-9900-57e8b99a5502 61 fields · synced Jun 1, 2026
- FDA UDI f347b08f-5cd3-4e81-9073-3f7cea4f4a6c 36 fields · synced May 27, 2026