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Gyn Cytology Test Kit

by Junocare Medical Devices Ltd 3 variants

Ref C0181JN18

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

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/IVDR NumberB-06973094411417 Basic UDI-DI 06973094411417UDI-DIDate15 Sep 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
C0181JN18
Primary DI / UDI-DI
06973094411417
Basic UDI-DI
B-06973094411417, 697309441TestKit6T
EMDN Code
W0103010301, W0580, W01019099
Device Class
Class I
Class A
EU market of registration
Greece
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000030653
Authorised representative
Humiss International B.V. NL-AR-000001490

Other devices from Junocare Medical Devices Ltd

See all devices from Junocare Medical Devices Ltd →

Properties

  • Human Tissues NoEUDAMEDYesEUDAMED
  • Reagent
  • Professional Testing
  • Companion Diagnostics
  • New Device

Other properties (14)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Administering Medicine: No
  • Measuring Function: No
  • Surgical Instrument: No
  • Incorporates Medicinal Product: No