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Dengue IgG/IgM/NS1 Combo Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref DEAB/DEAG-D35a
Identity
- Trade Name
- Dengue IgG/IgM/NS1 Combo Rapid Test EUDAMED
- Device Name
- Dengue IgG/IgM/NS1 Combo Rapid Test EUDAMED
- Model / Reference
- DEAB/DEAG-D35a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-DEAB/DEAG-D35aTS EUDAMED
- Basic UDI-DI
- B-DEAB/DEAG-D35aTS EUDAMED
- EMDN Code
- W0105099007 DENGUE - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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 IgG/IgM/NS1 Combo Rapid Test by Hangzhou Aichek Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-DEAB/DEAG-D35aTS | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 53870947-f144-4dc7-b0a2-5c1308a08f3c 61 fields · synced Jun 18, 2026