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ONE STEP Anti-TP (Treponema Pallidum/Syphilis) TEST
EUDAMEDClass IVD General (EU MDR)
Ref ITP03004-TC40Model ITP03004Ref ITP03004-DS50
Identity
- Trade Name
- ONE STEP Anti-TP (Treponema Pallidum/Syphilis) TEST EUDAMED
- Device Name
- ONE STEP Anti-TP (Treponema Pallidum/Syphilis) TEST EUDAMED
- Model / Reference
- ITP03004 EUDAMEDITP03004-TC40 EUDAMEDITP03004-DS50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936155804528 EUDAMED06936155804535 EUDAMED
- Basic UDI-DI
- B-06936155804528 EUDAMEDB-06936155804535 EUDAMED
- EMDN Code
- W0105090105 SYPHILIS - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Bulgaria 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 Anti-TP (Treponema Pallidum/Syphilis) 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-06936155804528 | 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 (4)
- EUDAMED c43bfe9c-ee45-40d5-8e63-97144ce56dd8 61 fields · synced Jul 12, 2026
- EUDAMED cbcb46e4-bf8e-4948-b00c-7dca217a5322 61 fields · synced May 19, 2026
- EUDAMED 5d825911-af46-49c1-8fd7-19d5c7861508 61 fields · synced Jun 11, 2026
- EUDAMED 3691510c-c8d0-445c-a096-6411ca30cbe7 61 fields · synced Jul 12, 2026