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Semi-Automatic Core Biopsy Instrument
EUDAMEDClass IIa (EU MDR)
Ref BN-OCR-4/1809/Ⅰ
Identity
- Device Name
- Semi-Automatic Core Biopsy Instrument EUDAMED
- Model / Reference
- BN-OCR-4/1809/Ⅰ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936666556879 EUDAMED
- Basic UDI-DI
- 697046733MBN-CBNQ3 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
Semi-Automatic Core Biopsy Instrument 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 | 697046733MBN-CBNQ3 | 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 5f48ff63-b408-4a9a-8bff-fa22f8ee372f 61 fields · synced Oct 5, 2026