Identity
- Device Name
- Disposable Coaxial Biopsy Needle EUDAMED
- Model / Reference
- BN-MAR-5/19116 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937278620019 EUDAMED
- Basic UDI-DI
- 697046733CBNQN EUDAMED
- EMDN Code
- A0102010101 SHEARING BIOPSY NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 Coaxial Biopsy Needle by Zhejiang CuraWay Medical Technology 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 | 697046733CBNQN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang CuraWay Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000025983
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED e3d37bf3-7809-43ce-90be-87a68c0c0e3f 61 fields · synced Oct 5, 2026