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hCG Card
EUDAMEDClass IVD General (EU MDR)
Ref 132-200/100Model 132-200/100 - 132-200 - 132-200/20 - 132-200/50
Identity
- Trade Name
- hCG Card EUDAMED
- Device Name
- hCG Card EUDAMED
- Model / Reference
- 132-200/100 - 132-200 - 132-200/20 - 132-200/50 EUDAMED132-200/100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404035100745 EUDAMED
- Basic UDI-DI
- B-05404035100745 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-05404035100745 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Cypress Diagnostics
- EUDAMED SRN
- BE-MF-000000033
Sources (1)
- EUDAMED 261d2ece-60da-4b2b-9f07-27f781db2141 61 fields · synced Jun 18, 2026