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LensHooke® Sperm Double Strand DNA Fragmentation Test Kit (SDFR assay)

by Bonraybio Co., LTD. EUDAMED

Active European Union

Ref R11Model R11 Plus

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number471987474R11PT Basic UDI-DIDate5 Sep 2024RegisteredStatusActive

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  • Withdrawn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

Device Name
LensHooke® Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)
Model / Reference
R11 Plus, R11
Primary DI / UDI-DI
04719874741747
Basic UDI-DI
471987474R11PT
EMDN Code
W0103010302 Romanowsky stains
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

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No