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HSV-II IgG (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320512901Model 50TRef 0320512903Model 100TRef 0320512904Model 2×100T
Identity
- Trade Name
- HSV-II IgG (eCLIA) EUDAMED
- Device Name
- HSV-II IgG (eCLIA) EUDAMED
- Model / Reference
- 50T EUDAMED0320512901 EUDAMED100T EUDAMED0320512903 EUDAMED2×100T EUDAMED0320512904 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978139070048 EUDAMED06978139070062 EUDAMED06978139070079 EUDAMED
- Basic UDI-DI
- B-06978139070048 EUDAMEDB-06978139070062 EUDAMEDB-06978139070079 EUDAMED
- EMDN Code
- W0105040309 HSV 2 IGG EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
HSV-II IgG (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-06978139070048 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (3)
- EUDAMED c699c332-767b-4297-82a0-41dca9043f0c 61 fields · synced Jul 29, 2026
- EUDAMED b22dadb1-36cc-4844-87cd-7caafdbf2d9a 61 fields · synced May 16, 2026
- EUDAMED 58d0e693-03ce-413e-a703-15e692275e12 61 fields · synced May 19, 2026