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Broach for Optima Cementless Stem
EUDAMEDClass I (EU MDR)
Ref B05127-1Ref B05125-1Ref B05128-1Ref B05126-1Ref B05123-1Ref B05131-1
Identity
- Device Name
- Broach for Optima Cementless Stem EUDAMED
- Model / Reference
- B05127-1 EUDAMEDB05125-1 EUDAMEDB05128-1 EUDAMEDB05126-1 EUDAMEDB05123-1 EUDAMEDB05131-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CNMF0000201152366J8 EUDAMEDD-CNMF0000201152364J4 EUDAMEDD-CNMF0000201152367JA EUDAMEDD-CNMF0000201152365J6 EUDAMEDD-CNMF0000201152362HY EUDAMEDD-CNMF0000201152370HX EUDAMED
- Basic UDI-DI
- B-CNMF0000201152366J8 EUDAMEDB-CNMF0000201152364J4 EUDAMEDB-CNMF0000201152367JA EUDAMEDB-CNMF0000201152365J6 EUDAMEDB-CNMF0000201152362HY EUDAMEDB-CNMF0000201152370HX 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 Optima Cementless 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-CNMF0000201152366J8 | 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 (6)
- EUDAMED 7704fd5f-93c7-47f1-b12c-87e5085976c1 61 fields · synced Aug 4, 2026
- EUDAMED bdf9ef6d-58cd-4ba1-8773-04b1a7925d68 61 fields · synced May 17, 2026
- EUDAMED 10d8b7d5-2324-4706-b6c8-1befcc863d8a 61 fields · synced May 17, 2026
- EUDAMED 9609d7b2-b906-4afc-a20a-b9ca2b597842 61 fields · synced May 18, 2026
- EUDAMED d85cbce7-f794-44d5-843d-4e00af41ffc8 61 fields · synced May 18, 2026
- EUDAMED 8f52fbbf-6a27-43ec-bdcc-7655aae6bb65 61 fields · synced May 18, 2026