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HCG Pregnancy Test (Colloidal Gold)
EUDAMEDClass B (EU MDR)
Ref HCG1UST-20Model Cassette Strip MidstreamRef HCG1UST -20
Identity
- Trade Name
- HCG Pregnancy Test (Colloidal Gold) EUDAMED
- Device Name
- HCG Pregnancy Test (Colloidal Gold) EUDAMED
- Model / Reference
- Cassette Strip Midstream EUDAMEDHCG1UST-20 EUDAMEDHCG1UST -20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952062779186 EUDAMED
- Basic UDI-DI
- 69520627J001KW EUDAMEDB-06952062779186 EUDAMED
- Unit of Use DI
- 06952062712695 EUDAMED
- EMDN Code
- W0102050205 TOTAL HUMAN CHORIONIC GONADOTROPIN EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass 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
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 B — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 69520627J001KW | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 69520627J001KW | Class B | 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 9c79c1c5-521b-4121-b599-a3c1648742d9 61 fields · synced Oct 8, 2026
- EUDAMED 1a3933c5-33e6-4d58-9942-cbc19ba9d081 61 fields · synced Oct 8, 2026