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Syphilis (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320509812Model 2×100TRef 0320509808Model 100TRef 0320509807Model 50TRef 0320509811Model 2×50T
Identity
- Trade Name
- Syphilis (eCLIA) EUDAMED
- Device Name
- Syphilis (eCLIA) EUDAMED
- Model / Reference
- 2×100T EUDAMED0320509812 EUDAMED100T EUDAMED0320509808 EUDAMED50T EUDAMED0320509807 EUDAMED2×50T EUDAMED0320509811 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984065274 EUDAMED06975984065205 EUDAMED06975984065236 EUDAMED06975984065267 EUDAMED
- Basic UDI-DI
- B-06975984065274 EUDAMEDB-06975984065205 EUDAMEDB-06975984065236 EUDAMEDB-06975984065267 EUDAMED
- EMDN Code
- W0105010302 SYPHILIS ANTIBODY ASSAYS TOTAL EUDAMED
Classification
- Device Class
- Class 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
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Syphilis (eCLIA) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06975984065274 | Class IVD General | 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 (4)
- EUDAMED bc5ee16f-897d-43e5-a639-f36914e4984b 61 fields · synced Jul 26, 2026
- EUDAMED 5c717f44-364b-49bf-946e-cd97c11a26db 61 fields · synced May 16, 2026
- EUDAMED b0290328-538b-4cb4-b696-723f580be560 61 fields · synced May 17, 2026
- EUDAMED 0dcd8f72-f22d-46c5-865d-f57592d21903 61 fields · synced May 17, 2026