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Total Beta Human Chorionic Gonadotropin (Total β-HCG) eCLIA
EUDAMEDClass B (EU MDR)
Ref 697042
Identity
- Trade Name
- Total Beta Human Chorionic Gonadotropin (Total β-HCG) eCLIA EUDAMED
- Device Name
- Total Beta Human Chorionic Gonadotropin (Total β-HCG) eCLIA EUDAMED
- Model / Reference
- 697042 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341680954 EUDAMED
- Basic UDI-DI
- 69703416803205006J7 EUDAMED
- EMDN Code
- W0102050206 B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Total Beta Human Chorionic Gonadotropin (Total β-HCG) eCLIA by Shenzhen Lifotronic Technology Co., Ltd. — Class B — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69703416803205006J7 | Class B | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 3a442097-cf9f-4812-9e84-13102c7dec29 61 fields · synced Jun 19, 2026