Profemur® PRFS0450
Ref PRFS0450
Profemur® PRFS0450 is a Class I device made by MicroPort Orthopedics Inc., registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 0192629IRHL09040278) and listed in FDA GUDID since 30 Dec 2016 (UDI-DI 00192629055742), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0192629IRHL09040278 00192629055742 | Date3 Nov 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00192629055742 | Date30 Dec 2016 | StatusListed |
Official records
- EUDAMED public site 0192629IRHL09040278
Across registries
- EUDAMED Basic UDI-DI 0192629IRHL09040278 registered 3 Nov 2026 Active
- FDA GUDID UDI-DI 00192629055742 listed 30 Dec 2016 Listed
Timeline
- Listed FDA GUDID 00192629055742
- Registered EUDAMED 0192629IRHL09040278
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Profemur® S & Tapered Stem Box Chisel EUDAMEDProfemur® GUDID
- Generic name
- Joint prosthesis implantation kit, reusable
- Device name
- Hip ORTHOPAEDIC SURGERY SCALPELS, REUSABLE
- Model / Ref / Catalog
- PRFS0450
- Primary DI / UDI-DI
- 00192629055742 EUDAMEDM684PRFS04501 GUDID
- Basic UDI-DI
- 0192629IRHL09040278
- Secondary DI
- M684PRFS04501
- Direct marketing DI
- 00192629055742
- FDA product code
- FZO
- EMDN code
- L090402 Orthopaedic surgery scalpels, reusable
- GMDN term
- Joint prosthesis implantation kit, reusable
- Device class
- Class I
- Regulation number
- 878.4800
- EU registration type
- Standard device
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Primary DI / UDI-DI | 00192629055742 | M684PRFS04501 |
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