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Tapered Reamer
EUDAMEDClass I (EU MDR)
Ref B04007-1Ref B08006Ref B08004Ref B04007-4Ref B08005Ref B08007
Identity
- Device Name
- Tapered Reamer EUDAMED
- Model / Reference
- B04007-1 EUDAMEDB08006 EUDAMEDB08004 EUDAMEDB04007-4 EUDAMEDB08005 EUDAMEDB08007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CNMF0000201152175HX EUDAMEDD-CNMF0000201152302HE EUDAMEDD-CNMF0000201152300HA EUDAMEDD-CNMF0000201152178J5 EUDAMEDD-CNMF0000201152301HC EUDAMEDD-CNMF0000201152303HG EUDAMED
- Basic UDI-DI
- B-CNMF0000201152175HX EUDAMEDB-CNMF0000201152302HE EUDAMEDB-CNMF0000201152300HA EUDAMEDB-CNMF0000201152178J5 EUDAMEDB-CNMF0000201152301HC EUDAMEDB-CNMF0000201152303HG 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
Tapered Reamer 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-CNMF0000201152175HX | 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 a9b9be67-25db-48b9-9d80-321238dc64f8 61 fields · synced Jul 31, 2026
- EUDAMED 7716222b-3c48-4256-b6dc-7b187e0c8dab 61 fields · synced May 18, 2026
- EUDAMED 8afc4e13-4eb9-4756-8317-2dddd41253af 61 fields · synced May 18, 2026
- EUDAMED 1e5459b9-b0f0-4ab0-a043-7155806d45a7 61 fields · synced May 19, 2026
- EUDAMED 456f9a9d-b2ff-4968-a899-edee1f88bff0 61 fields · synced May 19, 2026
- EUDAMED 7e158b6c-59eb-4214-a243-8f55648cdb2c 61 fields · synced May 19, 2026