Identity
- Trade Name
- CupiSURE EUDAMED
- Device Name
- Pregnancy hCG Test Kit EUDAMED
- Model / Reference
- CUPHCG-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906005288042 EUDAMED
- Basic UDI-DI
- 890600528cuphcgKG EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
CupiSURE by Cupid Limited — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 890600528cuphcgKG | Class B | Active |
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Manufacturer
- Manufacturer
- Cupid Limited
- EUDAMED SRN
- IN-MF-000033199
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (1)
- EUDAMED 72c79eeb-b98b-4833-b142-a4456b4233a4 61 fields · synced Jun 18, 2026