Profemur® APA09050
Ref APA09050
Profemur® APA09050 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 13 Apr 2017 (UDI-DI 00192629076488), 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 00192629076488 | Date3 Nov 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00192629076488 | Date13 Apr 2017 | StatusListed |
Official records
- EUDAMED public site 0192629IRHL09040278
Across registries
- EUDAMED Basic UDI-DI 0192629IRHL09040278 registered 3 Nov 2026 Active
- FDA GUDID UDI-DI 00192629076488 listed 13 Apr 2017 Listed
Timeline
- Listed FDA GUDID 00192629076488
- Registered EUDAMED 0192629IRHL09040278
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Profemur® Xm Chisel Box EUDAMEDProfemur® GUDID
- Generic name
- Joint prosthesis implantation kit, reusable
- Device name
- Hip ORTHOPAEDIC SURGERY SCALPELS, REUSABLE
- Model / Ref / Catalog
- APA09050
- Primary DI / UDI-DI
- 00192629076488 EUDAMEDM684APA090501 GUDID
- Basic UDI-DI
- 0192629IRHL09040278
- Secondary DI
- M684APA090501
- Direct marketing DI
- 00192629076488
- 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 | 00192629076488 | M684APA090501 |
Similar devices in this category
Other devices filed under ORTHOPAEDIC SURGERY SCALPELS, REUSABLE.
- INFINITY 33600119 by WRIGHT MEDICAL TECHNOLOGY, INC.
- SPINAL INSTRUMENT 202941 by MEDOS INTERNATIONAL SARL
- CONDUIT LET11400T by MEDOS INTERNATIONAL SARL
- Vanguard® 32-486150 by Biomet Orthopedics, Inc.
- Chisel attachment, modular 01.00129.660 by Zimmer, Inc.
- Box chisel 72.13.02-10 by Zimmer, Inc.
- FENTEX 120204FX by FENTEX medical GmbH
- U2 Total Knee System 2303-7054 by UNITED ORTHOPEDIC CORP.
- Instrumentation class I with measuring function ANC622 by Newclip Technics SAS