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hCG Card
EUDAMEDClass IVD General (EU MDR)
Ref 132-200/50Model 132-200/50 - 132-200 - 132-200/100 - 132-200/20Ref 132-200/20Model 132-200/20 - 132-200 - 132-200/100 - 132-200/50Ref 132-200Model 132-200 - 132-200/100 - 132-200/20 - 132-200/50
Identity
- Trade Name
- hCG Card EUDAMED
- Device Name
- hCG Card EUDAMED
- Model / Reference
- 132-200/50 - 132-200 - 132-200/100 - 132-200/20 EUDAMED132-200/50 EUDAMED132-200/20 - 132-200 - 132-200/100 - 132-200/50 EUDAMED132-200/20 EUDAMED132-200 - 132-200/100 - 132-200/20 - 132-200/50 EUDAMED132-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404035100769 EUDAMED05404035100752 EUDAMED05404035100738 EUDAMED
- Basic UDI-DI
- B-05404035100769 EUDAMEDB-05404035100752 EUDAMEDB-05404035100738 EUDAMED
- EMDN Code
- W0102050213 FREE BETA HCG (PRENATAL SCREENING) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
hCG Card by Cypress Diagnostics — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05404035100769 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Cypress Diagnostics
- EUDAMED SRN
- BE-MF-000000033
Sources (3)
- EUDAMED fc985a24-64b9-4efb-80e3-ed18f2d672d6 61 fields · synced Aug 2, 2026
- EUDAMED 0c84b805-993e-46d6-a69a-bd77f8a91ec4 61 fields · synced May 19, 2026
- EUDAMED 85014699-8ee6-4b7f-bd27-1c670c1384ff 61 fields · synced May 19, 2026