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ONE STEP Troponin I Test
EUDAMEDClass IVD General (EU MDR)
Ref ITP08001-TC40Model ITP08001
Identity
- Trade Name
- ONE STEP Troponin I Test EUDAMED
- Device Name
- ONE STEP Troponin I Test EUDAMED
- Model / Reference
- ITP08001 EUDAMEDITP08001-TC40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936155804542 EUDAMED
- Basic UDI-DI
- B-06936155804542 EUDAMED
- EMDN Code
- W0102160703 TROPONIN I/T - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General 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 Troponin I 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-06936155804542 | 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 428c3096-ee59-4355-b3e8-24c95b025960 61 fields · synced Jun 17, 2026