← Back to catalogue
Alpha-Fetoprotein (eCLIA)
EUDAMEDClass C (EU MDR)
Ref 0320501401Model 50T, 2x50T, 100T, 2x100TModel 50T
Identity
- Trade Name
- Alpha-Fetoprotein (eCLIA) EUDAMED
- Device Name
- Alpha-Fetoprotein (eCLIA) EUDAMED
- Model / Reference
- 50T, 2x50T, 100T, 2x100T EUDAMED0320501401 EUDAMED50T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341685713 EUDAMED
- Basic UDI-DI
- 69703416803205048JP EUDAMEDB-06970341685713 EUDAMED
- EMDN Code
- W0102039001 ALPHAFETOPROTEIN EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Alpha-Fetoprotein (eCLIA) by Shenzhen Lifotronic Technology Co., Ltd. — Class C — 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 | 69703416803205048JP | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 69703416803205048JP | Class C | 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 (2)
- EUDAMED e0562a99-9cd6-470c-a419-e0f74bb0fdfc 61 fields · synced Jul 11, 2026
- EUDAMED 6d5f5a67-d552-4e92-a829-e19b3bf02c7b 61 fields · synced May 17, 2026