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CupiKIT

by Cupid Limited India EUDAMED

Ref CUPHIV-01

EMDN W0105090302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number2026-IVDR/QS-002/A Date15 Oct 2026IssuedStatusActive expires 13 Oct 2030

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2026-IVDR/QS-002/A Amended

    Quality management system EU IVDR

    Notified body
    3EC International a.s. 2265
    Issued
    15 Oct 2026
    Expires
    13 Oct 2030
    Reason
    Ar data change
  • 2026-IVDR/TD-002/A Amended

    Technical documentation EU IVDR

    Notified body
    3EC International a.s. 2265
    Issued
    15 Oct 2026
    Expires
    13 Oct 2030
    Reason
    Ar data change

Specification

EUDAMED · synced 24 Oct 2026

Device Name
HIV 1 & 2 Antibody Test Kit
Model / Reference
CUPHIV-01
Primary DI / UDI-DI
08906005286055
Basic UDI-DI
890600528cuphiv1229
Direct Marketing DI
08906005286055
EMDN Code
W0105090302 HIV 1 / 2 - rt & poc
Device Class
Class D
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
IN-MF-000033199
Authorised representative
Amstermed B.V. NL-AR-000001971

Other devices from Cupid Limited

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Professional Testing
  • New Device
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 18486bd4-ab5c-4629-9e26-4211b0d2fe06 61 fields · synced 24 Oct 2026