Broach for Revision Stem
by Tianjin Zhengtian Medical Instrument Co., Ltd.
Ref B01053-4, B01053-1, B01053-2, B01053-3
Broach for Revision Stem (B01053-4) is a Class I device made by Tianjin Zhengtian Medical Instrument Co., Ltd., registered in EUDAMED on 14 Apr 2025 (Basic UDI-DI B-CNMF0000201152503HS), active as of 22 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-CNMF0000201152503HS | Date14 Apr 2025 | StatusActive |
Official records
- EUDAMED public site B-CNMF0000201152503HS
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device name
- Broach for Revision Stem
- Model / reference
- B01053-4, B01053-1, B01053-2, B01053-3
- Primary DI / UDI-DI
- D-CNMF0000201152503HS, D-CNMF0000201152500HL, D-CNMF0000201152501HN, D-CNMF0000201152502HQ
- Basic UDI-DI
- B-CNMF0000201152503HS, B-CNMF0000201152500HL, B-CNMF0000201152501HN, B-CNMF0000201152502HQ
- EMDN code
- L091102 Orthopaedic prostheses reamers and burs, reusable
- Device class
- Class I
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Portugal
Manufacturer details
- EUDAMED SRN
- CN-MF-000020115
- Authorised representative
- Inion Oy FI-AR-000046224
Similar devices in this category
Other devices filed under ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE.
- Vanguard® Instruments 32-486809 by Biomet Orthopedics, Inc.
- Trabecular Metal® 00-4309-042-02 by Zimmer, Inc.
- 9801-41 00-9801-041-00 by Zimmer, Inc.
- Humelock II Cemented Shoulder System 451-0019 by FX SOLUTIONS
- U2 Total Knee System 9323-3514 by UNITED ORTHOPEDIC CORP.
- U2™ Knee 9403-3010-RB by UNITED ORTHOPEDIC CORP.
- Aequalis Reversed Fracture MWD215 by TORNIER, INC.
- Keep Walking Reusable Surgical Devices TGUI0010000 by TEQUIR S.L.
- U2 Hip Stem 9104-3116 by United Orthopedic Corporation
- WasherCap™ Countersink 9mm ATMWCIN05 by ABANZA TECNOMED, S.L.
Other devices from Tianjin Zhengtian Medical Instrument Co., Ltd.
See all devices from Tianjin Zhengtian Medical Instrument Co., Ltd. →