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hCG Dipstrip
EUDAMEDClass IVD General (EU MDR)
Ref 132-100Model 132-100 - 132-100/100 - 132-100/50Ref 132-100/50Model 132-100/50 - 132-100 - 132-100/100Ref 132-100/100Model 132-100/100 - 132-100 - 132-100/50
Identity
- Trade Name
- hCG Dipstrip EUDAMED
- Device Name
- hCG Dipstrip EUDAMED
- Model / Reference
- 132-100 - 132-100/100 - 132-100/50 EUDAMED132-100 EUDAMED132-100/50 - 132-100 - 132-100/100 EUDAMED132-100/50 EUDAMED132-100/100 - 132-100 - 132-100/50 EUDAMED132-100/100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404035100707 EUDAMED05404035100721 EUDAMED05404035100714 EUDAMED
- Basic UDI-DI
- B-05404035100707 EUDAMEDB-05404035100721 EUDAMEDB-05404035100714 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 Dipstrip 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-05404035100707 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Cypress Diagnostics
- EUDAMED SRN
- BE-MF-000000033
Sources (3)
- EUDAMED 14ec90fa-221d-4e62-875c-84f6e2067f6e 61 fields · synced Jul 29, 2026
- EUDAMED 23823fa8-fabe-4d00-af83-3b9950796d24 61 fields · synced May 17, 2026
- EUDAMED 66603402-56b6-44bf-ad62-5663c17b16d5 61 fields · synced May 18, 2026