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FertiQUICK

by NanoRepro AG Germany EUDAMED

Ref 820008

EMDN W0102160399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-820008P5 Basic UDI-DIDate11 Nov 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • D1368900058 Supplemented

    Technical documentation EU IVDR

    Notified body
    Notified body 0483
    Issued
    13 Mar 2026
    Expires
    19 Jan 2030
    Reason
    Other

Specification

EUDAMED · synced 24 Oct 2026

Device Name
FertiQUICK [BG/EN]
FertiQUICK ( 820001, DE/EN)
Model / Reference
820008
Primary DI / UDI-DI
D-820008P5, 112027265793
Basic UDI-DI
B-820008P5, PP0390882000156
Direct Marketing DI
112027265793
EMDN Code
W0102160399, W0201069099
Device Class
Class IVD devices for self-testing
Class B
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
DE-MF-000023735

Other devices from NanoRepro AG

See all devices from NanoRepro AG →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Self Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 9cc5d278-9f14-49f3-8a95-02ebae8e2b1b 61 fields · synced 24 Oct 2026
  • EUDAMED 112027265793|PP0390882000156 61 fields · synced 24 Oct 2026