← Back to catalogue

CupiKIT

EUDAMED

Class C (EU MDR)

Ref CUPSYP-01Ref CUPHBS-01Ref CUPHIV-01

by Cupid Limited

Identity

Trade Name
CupiKIT EUDAMED
Device Name
Syphilis Antibody Test Kit EUDAMED
Hepatitis B Surface Antigen (HBsAg) Test Kit EUDAMED
HIV 1 & 2 Antibody Test Kit EUDAMED
Model / Reference
CUPSYP-01 EUDAMED
CUPHBS-01 EUDAMED
CUPHIV-01 EUDAMED

Identifiers

Primary DI / UDI-DI
08906005286086 EUDAMED
08906005286024 EUDAMED
08906005286055 EUDAMED
Basic UDI-DI
890600528cupsypPT EUDAMED
890600528cuphbsL5 EUDAMED
890600528cuphiv1229 EUDAMED
Direct Marketing DI
08906005286024 EUDAMED
08906005286055 EUDAMED
EMDN Code
W0105090105 SYPHILIS - RT & POC EUDAMED
W0105090201 HBSAG - RT & POC EUDAMED
W0105090302 HIV 1 / 2 - RT & POC EUDAMED

Classification

Device Class
Class C EUDAMED
Class D EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMEDEUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

Yes

EUDAMED

CupiKIT by Cupid Limited — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Cupid Limited
EUDAMED SRN
IN-MF-000033199
Authorised Representative
Amstermed B.V. NL-AR-000001971

Sources (3)

  • EUDAMED 94c2b0eb-ce40-4a13-a7eb-0ca924f3307e 61 fields · synced Jul 22, 2026
  • EUDAMED a1a439ef-f4af-4ee5-be84-2c3842c7f9da 61 fields · synced Jul 16, 2026
  • EUDAMED 18486bd4-ab5c-4629-9e26-4211b0d2fe06 61 fields · synced Jul 22, 2026