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Dengue Virus NS1 Antigen Rapid Test Kit (Lateral Flow Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 0201002839Model 40 tests/kit
Identity
- Trade Name
- Dengue Virus NS1 Antigen Rapid Test Kit (Lateral Flow Immunoassay) EUDAMED
- Device Name
- Dengue Virus NS1 Antigen Rapid Test Kit (Lateral Flow Immunoassay) EUDAMED
- Model / Reference
- 40 tests/kit EUDAMED0201002839 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971140521080 EUDAMED
- Basic UDI-DI
- B-06971140521080 EUDAMED
- EMDN Code
- W01050499 VIROLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
Dengue Virus NS1 Antigen Rapid Test Kit (Lateral Flow Immunoassay) by Beijing Kinghawk Pharmaceutical 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-06971140521080 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Kinghawk Pharmaceutical CO., Ltd
- EUDAMED SRN
- CN-MF-000052726
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 5c5049ca-4798-45fb-9340-67bb13135a55 61 fields · synced Jul 31, 2026