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Dengue Rapid Test
EUDAMEDClass B (EU MDR)
Ref A42870Model Format (cassette): A4287011 A42870125 A42870140 A4287021 A42870225 A42870240Ref Den-W23M NS1-W23
Identity
- Trade Name
- Dengue Rapid Test EUDAMED
- Device Name
- Dengue Rapid Test EUDAMED
- Model / Reference
- Format (cassette): A4287011 A42870125 A42870140 A4287021 A42870225 A42870240 EUDAMEDA42870 EUDAMEDDen-W23M NS1-W23 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804832728 EUDAMED06952804816490 EUDAMED
- Basic UDI-DI
- 69528048A4287002H EUDAMEDB-06952804816490 EUDAMED
- EMDN Code
- W0105040611 DENGUE VIRUS EUDAMEDW0105099007 DENGUE - RT & POC EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Spain EUDAMEDNetherlands 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
New Device
No
EUDAMED
Dengue Rapid Test by Assure Tech. (hangzhou) Co., Ltd. — Class B — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 69528048A4287002H | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 69528048A4287002H | Class B | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED cd03611f-6122-4c17-8835-487c94ac7bb6 61 fields · synced Jul 25, 2026
- EUDAMED bfc6fb5d-f406-4a44-8b34-e067cf0f1e09 61 fields · synced May 18, 2026