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HCG Pregnancy Test (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref HCG3UST -50Model Cassette Strip Midstream
Identity
- Trade Name
- HCG Pregnancy Test (Colloidal Gold) EUDAMED
- Device Name
- HCG Pregnancy Test (Colloidal Gold) EUDAMED
- Model / Reference
- Cassette Strip Midstream EUDAMEDHCG3UST -50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952062779216 EUDAMED
- Basic UDI-DI
- B-06952062779216 EUDAMED69520627J001KW EUDAMED
- Unit of Use DI
- 06952062712695 EUDAMED
- EMDN Code
- W0102050205 TOTAL HUMAN CHORIONIC GONADOTROPIN EUDAMED
Classification
- Device Class
- Class IVD General 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
Yes
EUDAMED
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
HCG Pregnancy Test (Colloidal Gold) by Anhui Deepblue Medical Technology Co., Ltd — Class IVD General — 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-06952062779216 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06952062779216 | Class IVD General | 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 dc104e65-506b-4ddc-81ec-93bf098344e0 61 fields · synced Oct 8, 2026
- EUDAMED bfa41b65-9e29-4f72-8862-4b27ff9206ab 61 fields · synced Oct 8, 2026