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Dengue NS1 Antigen Test (GICA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320321102Model 25T
Identity
- Trade Name
- Dengue NS1 Antigen Test (GICA) EUDAMED
- Device Name
- Dengue NS1 Antigen Test (GICA) EUDAMED
- Model / Reference
- 25T EUDAMED0320321102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978139078150 EUDAMED
- Basic UDI-DI
- B-06978139078150 EUDAMED
- EMDN Code
- W0105099007 DENGUE - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Dengue NS1 Antigen Test (GICA) 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-06978139078150 | 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 (1)
- EUDAMED e289cc1b-8f02-48eb-8aef-cbf615051e28 61 fields · synced Jun 18, 2026