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ONE STEP Anti-HIV (1&2) Test
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref ITP02153-TC10Ref ITP02152-TC25Ref ITP02153-TC40
Identity
- Device Name
- ONE STEP Anti-HIV (1&2) Test EUDAMED
- Model / Reference
- ITP02153-TC10 EUDAMEDITP02152-TC25 EUDAMEDITP02153-TC40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936155804344 EUDAMED06936155804320 EUDAMED06936155804351 EUDAMED
- Basic UDI-DI
- B-06936155804344 EUDAMEDB-06936155804320 EUDAMEDB-06936155804351 EUDAMED
- EMDN Code
- W0105030402 HIV MULTIPLE ANTIBODY EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMED
- Market of Registration
- Portugal EUDAMEDBulgaria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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 Anti-HIV (1&2) Test by InTec PRODUCTS, INC. — Class IVD Annex II List A — 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-06936155804344 | Class IVD Annex II List A | 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 18aa2112-4bb6-4492-a416-34a3c2c4b416 61 fields · synced Oct 6, 2026
- EUDAMED 9e246d00-596d-4aee-b267-40f2e359ecc7 61 fields · synced May 18, 2026
- EUDAMED 49e92e3f-f95c-4249-b4bc-ef4ac8b8a086 61 fields · synced May 19, 2026