Identity
- Device Name
- Disposable Biopsy Needle EUDAMED
- Model / Reference
- BN-MAR-2/1818 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937278608505 EUDAMED
- Basic UDI-DI
- 697046733PTCTP EUDAMED
- EMDN Code
- A01020102 ASPIRATION FINE NEEDLES AND KITS 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
Category: Diskectomy system, percutaneous, automatic
Disposable Biopsy Needle by Zhejiang CuraWay Medical Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Diskectomy system, percutaneous, automatic.
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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 | 697046733PTCTP | 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 b7fffa34-5a80-403d-9c30-fbe34ce2b3b0 61 fields · synced Jul 23, 2026