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BM Zebra Nitinol Core Guidewire With Hydrophilic Tip

by Bonree Medical Co., Ltd. 5 variants

Ref 325 38 01 2Model Zebra Guidewire：0.018”, 0.025”, 0.028”, 0.032”, 0.035”, 0.038” "

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697209192GDWZ19N6 Basic UDI-DI 06942382610979UDI-DIDate29 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Guidewires
Model / Reference
Zebra Guidewire：0.018”, 0.025”, 0.028”, 0.032”, 0.035”, 0.038” ", 325 38 01 2
Primary DI / UDI-DI
06942382610979
Basic UDI-DI
697209192GDWZ19N6
Direct Marketing DI
06942382610979
EMDN Code
U0602 Urological guidewires, not hydrophilic
Device Class
Class IIa
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000017844
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Bonree Medical Co., Ltd.

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Properties

  • 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