Soft Reamer Head
by Tianjin Zhengtian Medical Instrument Co., Ltd. 12 variants
Ref D12044-4, D12044-9, D12044-1, D07044-8, D07044-1, D07044-4, D12044-11, D07044-9, D12044-2, D12044-5, D12044-3
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-CNMF0000201151044H8 | Date11 Sep 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- Soft Reamer Head
- Model / Reference
- D12044-4, D12044-9, D12044-1, D07044-8, D07044-1, D07044-4, D12044-11, D07044-9, D12044-2, D12044-5, D12044-3
- Primary DI / UDI-DI
- D-CNMF0000201151044H8, D-CNMF0000201151049HJ, D-CNMF0000201151039HF, D-CNMF0000201150945JG, D-CNMF0000201150940J6, D-CNMF0000201150941J8, D-CNMF0000201151041H2, D-CNMF0000201150946JJ, D-CNMF0000201151042H4, D-CNMF0000201151045HA, D-CNMF0000201151043H6
- Basic UDI-DI
- B-CNMF0000201151044H8, B-CNMF0000201151049HJ, B-CNMF0000201151039HF, B-CNMF0000201150945JG, B-CNMF0000201150940J6, B-CNMF0000201150941J8, B-CNMF0000201151041H2, B-CNMF0000201150946JJ, B-CNMF0000201151042H4, B-CNMF0000201151045HA, B-CNMF0000201151043H6
- EMDN Code
- L091102 Orthopaedic prostheses reamers and burs, reusable
- Device Class
- Class I
- EU market of registration
- SpainPortugal
Manufacturer details
- EUDAMED SRN
- CN-MF-000020115
- Authorised representative
- Inion Oy FI-AR-000046224
Other devices from Tianjin Zhengtian Medical Instrument Co., Ltd.
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Properties
Other properties (10)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No