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Distal Reamer
EUDAMEDClass I (EU MDR)
Ref B14045Ref B14046Ref C59011Ref C59013Ref C59012
Identity
- Device Name
- Distal Reamer EUDAMED
- Model / Reference
- B14045 EUDAMEDB14046 EUDAMEDC59011 EUDAMEDC59013 EUDAMEDC59012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CNMF0000201152438J8 EUDAMEDD-CNMF0000201152439JA EUDAMEDD-CNMF0000201150480HR EUDAMEDD-CNMF0000201150482HV EUDAMEDD-CNMF0000201150481HT EUDAMED
- Basic UDI-DI
- B-CNMF0000201152438J8 EUDAMEDB-CNMF0000201152439JA EUDAMEDB-CNMF0000201150480HR EUDAMEDB-CNMF0000201150482HV EUDAMEDB-CNMF0000201150481HT 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
Distal 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-CNMF0000201152438J8 | 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 (5)
- EUDAMED dc92137b-1a34-4a7d-8b15-96c41a8fe6f3 61 fields · synced Aug 1, 2026
- EUDAMED 16cdb0cd-67af-42ee-bc7c-662999ebb1d9 61 fields · synced May 17, 2026
- EUDAMED d100bcb0-eeaf-4117-bd42-d3268ef5bbe7 61 fields · synced May 18, 2026
- EUDAMED 5725e83a-8422-4818-9f94-7c19fd595bb5 61 fields · synced May 18, 2026
- EUDAMED f81b9de2-d924-4b8f-840b-ff165b01b870 61 fields · synced May 19, 2026