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Broach for Cemented Stem
EUDAMEDClass I (EU MDR)
Ref B04025-4Ref B04025-3Ref B14012Ref B14047Ref B14044Ref B15003Ref B04025-2
Identity
- Device Name
- Broach for Cemented Stem EUDAMED
- Model / Reference
- B04025-4 EUDAMEDB04025-3 EUDAMEDB14012 EUDAMEDB14047 EUDAMEDB14044 EUDAMEDB15003 EUDAMEDB04025-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CNMF0000201152190HT EUDAMEDD-CNMF0000201152189JA EUDAMEDD-CNMF0000201152407HV EUDAMEDD-CNMF0000201152410HJ EUDAMEDD-CNMF0000201152436J4 EUDAMEDD-CNMF0000201152444J3 EUDAMEDD-CNMF0000201152188J8 EUDAMED
- Basic UDI-DI
- B-CNMF0000201152190HT EUDAMEDB-CNMF0000201152189JA EUDAMEDB-CNMF0000201152407HV EUDAMEDB-CNMF0000201152410HJ EUDAMEDB-CNMF0000201152436J4 EUDAMEDB-CNMF0000201152444J3 EUDAMEDB-CNMF0000201152188J8 EUDAMED
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Acetabular orthopaedic reamer
Broach for Cemented Stem by Tianjin Zhengtian Medical Instrument Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-CNMF0000201152190HT | Class I | Active |
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Manufacturer
- Manufacturer
- Tianjin Zhengtian Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000020115
- Authorised Representative
- Inion Oy FI-AR-000046224
Sources (7)
- EUDAMED 6537a9b4-4c88-4b7b-b084-97e15f329683 61 fields · synced Jul 28, 2026
- EUDAMED 170a52c8-6ad3-4b26-9df2-698da39a3463 61 fields · synced May 17, 2026
- EUDAMED 9be9ae4e-5270-44ac-8b50-fa5abf623244 61 fields · synced May 17, 2026
- EUDAMED d54ebdb9-0bc8-4a9b-b05a-d4e8e8c9e631 61 fields · synced May 17, 2026
- EUDAMED e5caf9ab-1ac6-4f7f-8e98-179e4fdf93ba 61 fields · synced May 17, 2026
- EUDAMED e8f9e67e-89d4-4f2e-9797-f88306eb79db 61 fields · synced May 18, 2026
- EUDAMED 4685ef78-0476-4690-a83f-b880409f45e7 61 fields · synced May 19, 2026