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LensHooke® X QC Image (For Semen)

by Bonraybio Co., LTD. EUDAMED

Active European Union

Ref QXDModel X QC Image

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number471987474QXDUC Basic UDI-DIDate30 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
X QC Image, QXD
Primary DI / UDI-DI
14719874744035
Basic UDI-DI
471987474QXDUC
EMDN Code
W05039099 Devices for samples analyses - other
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000029512
Authorised representative
MDSS GmbH DE-AR-000005430

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Properties

Show properties
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No