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HCG Pregnancy Test (Colloidal Gold)
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref HCG3UST-1Model Midstream
Identity
- Trade Name
- HCG Pregnancy Test (Colloidal Gold) EUDAMED
- Device Name
- HCG Pregnancy Test (Colloidal Gold) EUDAMEDThe HCG Pregnancy Test(Colloidal Gold) EUDAMED
- Model / Reference
- HCG3UST-1 EUDAMEDMidstream EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952062777823 EUDAMED06952062770633 EUDAMED
- Basic UDI-DI
- B-06952062777823 EUDAMEDB-06952062770633 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMEDW0102050205 TOTAL HUMAN CHORIONIC GONADOTROPIN EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Italy EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMEDEUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
HCG Pregnancy Test (Colloidal Gold) by Anhui Deepblue Medical Technology Co., Ltd — Class IVD devices for self-testing — 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-06952062777823 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Anhui Deepblue Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000018785
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED 75c9899c-2717-49c0-baca-841d27678d57 61 fields · synced Oct 7, 2026
- EUDAMED 7d12d4a6-4444-446c-aa12-771d2f931aad 61 fields · synced Jul 29, 2026