← Back to catalogue
Dengue Antigen Test Kit (Immunofluorescence Method)
EUDAMEDClass IVD General (EU MDR)
Ref W-IF2-DEN-20Model 20 tests/kitRef W-IF2-DEN-40Model 40 tests/kit
Identity
- Device Name
- Dengue Antigen Test Kit (Immunofluorescence Method) EUDAMED
- Model / Reference
- 20 tests/kit EUDAMEDW-IF2-DEN-20 EUDAMED40 tests/kit EUDAMEDW-IF2-DEN-40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978896416080 EUDAMED06978896416097 EUDAMED
- Basic UDI-DI
- B-06978896416080 EUDAMEDB-06978896416097 EUDAMED
- EMDN Code
- W0105040511 DENGUE VIRUS - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania 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 Antigen Test Kit (Immunofluorescence Method) by Wuhan Easydiagnosis Biomedicine 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-06978896416080 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wuhan Easydiagnosis Biomedicine Co., Ltd.
- EUDAMED SRN
- CN-MF-000019908
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 7f8c771c-9ec8-4a96-abfa-a2a7ff435894 61 fields · synced Oct 6, 2026
- EUDAMED 792896b7-1e5a-44dd-abd1-f22238096fe3 61 fields · synced May 18, 2026