← Back to catalogue
Total Beta Human Chorionic Gonadotropin (Total β-HCG) eCLIA
EUDAMEDClass B (EU MDR)
Ref 697041Ref 697039Ref 697040
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
- 697041 EUDAMED697039 EUDAMED697040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341685959 EUDAMED06970341685942 EUDAMED06975984062143 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 541a23d8-cd47-4582-8c76-3fb471882fe3 61 fields · synced Jul 30, 2026
- EUDAMED 0e2cf9bf-d2cb-409a-b790-7a15eca3f063 61 fields · synced May 11, 2026
- EUDAMED d52f3830-cc8f-49f6-bf8b-6a9bd1ebd8b4 61 fields · synced May 16, 2026