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Biopsy Valve

by Yangzhou Fartley Medical Instrument Technology Co., Ltd. 3 variants

Ref EVKO-1S, 30018, EVKP-1S, 115291

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69709008510147Y Basic UDI-DI Date24 Mar 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  • Withdrawn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

Trade Name
Biopsy Valve
PENTAX Medical Single Use Biopsy Valve
Device Name
Disposable Endoscopy Adapter Sets
Model / Reference
EVKO-1S, 30018, EVKP-1S, 115291
Primary DI / UDI-DI
06936603217542, 06936603216095, 06936603217566, 06936603216507
Basic UDI-DI
69709008510147Y
Direct Marketing DI
06936603217542
06936603216095
06936603217566
06936603216507
EMDN Code
G0380 Digestive endoscopy devices - accessories
Device Class
Class I
EU market of registration
Germany
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000009371
Authorised representative
Prolinx GmbH DE-AR-000005129

Other devices from Yangzhou Fartley Medical Instrument Technology Co., Ltd

See all devices from Yangzhou Fartley Medical Instrument Technology Co., Ltd →

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