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HCG Pregnancy Test (Urine/Serum/Plasma) (ColloidalGold)
EUDAMEDClass IVD General (EU MDR)
Ref HCG USPModel Cassette
Identity
- Trade Name
- HCG Pregnancy Test (Urine/Serum/Plasma) (ColloidalGold) EUDAMED
- Device Name
- HCG Pregnancy Test (Urine/Serum/Plasma) (Colloidal Gold) EUDAMED
- Model / Reference
- Cassette EUDAMEDHCG USP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952062771524 EUDAMED
- Basic UDI-DI
- B-06952062771524 EUDAMED
- EMDN Code
- W0102050205 TOTAL HUMAN CHORIONIC GONADOTROPIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
HCG Pregnancy Test (Urine/Serum/Plasma) (ColloidalGold) by Anhui Deepblue Medical Technology Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
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-06952062771524 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Anhui Deepblue Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000018785
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 42365559-57af-4b6d-a119-7c4e7dcf3081 61 fields · synced Oct 6, 2026