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HSV-II IgM (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320512802Model 2×50TRef 0320512804Model 2×100TRef 0320512803Model 100T
Identity
- Trade Name
- HSV-II IgM (eCLIA) EUDAMED
- Device Name
- HSV-II IgM (eCLIA) EUDAMED
- Model / Reference
- 2×50T EUDAMED0320512802 EUDAMED2×100T EUDAMED0320512804 EUDAMED100T EUDAMED0320512803 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978139070017 EUDAMED06978139070031 EUDAMED06978139070024 EUDAMED
- Basic UDI-DI
- B-06978139070017 EUDAMEDB-06978139070031 EUDAMEDB-06978139070024 EUDAMED
- EMDN Code
- W0105040310 HSV 2 IGM 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 IgM (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-06978139070017 | 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 9963f9c0-0eff-424a-b292-2d5abbcb66d3 61 fields · synced Oct 1, 2026
- EUDAMED 91c0dab2-4932-4d4a-8841-95dc41cfb6d6 61 fields · synced May 17, 2026
- EUDAMED fafeb571-2c3c-4e5b-bab4-dedc282e7121 61 fields · synced May 18, 2026