Identity
- Device Name
- Disposable Biopsy Device EUDAMED
- Model / Reference
- F40205 EUDAMEDF40204 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937893902873 EUDAMED06937893902842 EUDAMED
- Basic UDI-DI
- 69378939F4066 EUDAMED
- EMDN Code
- A0102010101 SHEARING BIOPSY NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Biopsy Device by Tonglu Qianyan Medtech Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69378939F4066 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Tonglu Qianyan Medtech Co., Ltd
- EUDAMED SRN
- CN-MF-000017342
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (2)
- EUDAMED 906220be-9f5b-4f68-b714-4c27731a39f9 61 fields · synced Jul 24, 2026
- EUDAMED bda3023c-e5b3-4059-bc69-02b5fb72f689 61 fields · synced May 16, 2026