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Automatic Core Biopsy Instrument

by Zhejiang CuraWay Medical Technology Co., Ltd. China EUDAMED

Ref BN-OCR-1/1418/Ⅰ EMDN A0102010101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697046733ABN-CBNHP Basic UDI-DIDate26 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Automatic Core Biopsy Instrument
Model / Reference
BN-OCR-1/1418/Ⅰ
Primary DI / UDI-DI
06936666554264
Basic UDI-DI
697046733ABN-CBNHP
EMDN Code
A0102010101 Shearing biopsy needles
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000025983
Authorised representative
Prolinx GmbH DE-AR-000005129

Other devices from Zhejiang CuraWay Medical Technology Co., Ltd.

See all devices from Zhejiang CuraWay Medical Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 06936666554264|697046733ABN-CBNHP 61 fields · synced 24 Oct 2026