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Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test
EUDAMEDClass IVD General (EU MDR)
Ref ITP71004-TC10Model ITP71004Ref ITP71004-TC1Ref ITP71004-TC20
Identity
- Trade Name
- Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test EUDAMED
- Device Name
- Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test EUDAMED
- Model / Reference
- ITP71004 EUDAMEDITP71004-TC10 EUDAMEDITP71004-TC1 EUDAMEDITP71004-TC20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936155804498 EUDAMED06936155804481 EUDAMED06936155803767 EUDAMED
- Basic UDI-DI
- B-06936155804498 EUDAMEDB-06936155804481 EUDAMEDB-06936155803767 EUDAMED
- EMDN Code
- W0105099007 DENGUE - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Bulgaria EUDAMEDFrance 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
Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test by InTec PRODUCTS, INC. — 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-06936155804498 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- InTec PRODUCTS, INC.
- EUDAMED SRN
- CN-MF-000023625
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (3)
- EUDAMED 28ef97b6-871d-4b01-871d-d82cf53ef67f 61 fields · synced Jul 14, 2026
- EUDAMED 2388af45-4ebe-42a1-8f44-cf63e5cd92c8 61 fields · synced May 17, 2026
- EUDAMED a319f043-7f0a-4393-a2b4-6b99b31b8adc 61 fields · synced Jul 14, 2026