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One Step Dengue NS1 Ag Test
EUDAMEDClass IVD General (EU MDR)
Ref ITP71003-TC40Model ITP71003
Identity
- Trade Name
- One Step Dengue NS1 Ag Test EUDAMED
- Device Name
- One Step Dengue NS1 Ag Test EUDAMED
- Model / Reference
- ITP71003 EUDAMEDITP71003-TC40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936155804474 EUDAMED06936155803750 EUDAMED
- Basic UDI-DI
- B-06936155804474 EUDAMEDB-06936155803750 EUDAMED
- EMDN Code
- W0101060399 FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER EUDAMEDW0105099007 DENGUE - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece 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
One Step Dengue NS1 Ag 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-06936155804474 | 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 (2)
- EUDAMED c5ca6f9e-dc7e-4f71-9f20-3012ba1cc44f 61 fields · synced Jul 15, 2026
- EUDAMED 5b274fa3-f20c-45e6-9b48-5ae9dd46d434 61 fields · synced Jul 15, 2026