Identity
- Device Name
- Soft Drill EUDAMED
- Model / Reference
- C11001 EUDAMEDA63021 EUDAMEDA35024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CNMF0000201150106GW EUDAMEDD-CNMF0000201151967JZ EUDAMEDD-CNMF0000201151656JD EUDAMED
- Basic UDI-DI
- B-CNMF0000201150106GW EUDAMEDB-CNMF0000201151967JZ EUDAMEDB-CNMF0000201151656JD 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
Soft Drill 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-CNMF0000201150106GW | 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 (3)
- EUDAMED 12b90b3b-a485-43de-9bcc-9248b3265bec 61 fields · synced Jul 22, 2026
- EUDAMED 3bf6b205-c101-4331-b232-9f4f00e07951 61 fields · synced May 17, 2026
- EUDAMED 3e4c99e6-dc95-4dde-9916-41864334f486 61 fields · synced May 19, 2026