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The HCG Pregnancy Test (Colloidal Gold)
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref HCG3UST-2Model MidstreamRef HCG3UST -2Model Cassette Strip Midstream
Identity
- Trade Name
- The HCG Pregnancy Test (Colloidal Gold) EUDAMEDHCG Pregnancy Test (Colloidal Gold) EUDAMED
- Device Name
- HCG Pregnancy Test (Colloidal Gold) EUDAMED
- Model / Reference
- Midstream EUDAMEDHCG3UST-2 EUDAMEDCassette Strip Midstream EUDAMEDHCG3UST -2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952062770640 EUDAMED
- Basic UDI-DI
- B-06952062770640 EUDAMED69520627J001KW EUDAMED
- Unit of Use DI
- 06952062712695 EUDAMED
- EMDN Code
- W0102050205 TOTAL HUMAN CHORIONIC GONADOTROPIN EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMEDClass B 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
EUDAMEDEUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
The HCG Pregnancy Test (Colloidal Gold) by Anhui Deepblue Medical Technology Co., Ltd — Class IVD devices for self-testing — IVDR, IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06952062770640 | Class IVD devices for self-testing | Active |
| EUDAMED | European Union | CE/IVDD | B-06952062770640 | 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 2b99e6c9-d1a3-4dd4-9572-ca9c9d004754 61 fields · synced Oct 7, 2026
- EUDAMED 54209f97-3e0e-457d-8907-ef1603b0c978 61 fields · synced Oct 7, 2026