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ONE STEP Malaria(p.f/p.v) Tri-line Test
EUDAMEDClass IVD General (EU MDR)
Ref ITP11003-TC25Model ITP11003
Identity
- Trade Name
- ONE STEP Malaria(p.f/p.v) Tri-line Test EUDAMED
- Device Name
- ONE STEP Malaria(p.f/p.v) Tri-line Test EUDAMED
- Model / Reference
- ITP11003 EUDAMEDITP11003-TC25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936155804382 EUDAMED
- Basic UDI-DI
- B-06936155804382 EUDAMED
- EMDN Code
- W0105090401 PLASMODIUM (MALARIA) - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium 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 Malaria(p.f/p.v) Tri-line 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-06936155804382 | 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 (1)
- EUDAMED 2cc40e8a-6ead-47c4-a4bf-9b4da697a68d 61 fields · synced Jun 20, 2026