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ONE STEP Myoglobin/CK-MB-cTnI Combo TEST
EUDAMEDClass IVD General (EU MDR)
Ref ITP08101-TC20Model ITP08101Ref ITP08004-TC40Model ITP08004Ref ITP08003-TC40Model ITP08003
Identity
- Trade Name
- ONE STEP Myoglobin/CK-MB-cTnI Combo TEST EUDAMEDONE STEP CK-MB Test EUDAMEDONE STEP Myoglobin Test EUDAMED
- Device Name
- ONE STEP Myoglobin/CK-MB-cTnI Combo TEST EUDAMEDONE STEP CK-MB Test EUDAMEDONE STEP Myoglobin Test EUDAMED
- Model / Reference
- ITP08101 EUDAMEDITP08101-TC20 EUDAMEDITP08004 EUDAMEDITP08004-TC40 EUDAMEDITP08003 EUDAMEDITP08003-TC40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936155804559 EUDAMED06936155803798 EUDAMED06936155803781 EUDAMED06936155803774 EUDAMED
- Basic UDI-DI
- B-06936155804559 EUDAMEDB-06936155803798 EUDAMEDB-06936155803781 EUDAMEDB-06936155803774 EUDAMED
- EMDN Code
- W0102160706 MULTIPLE CARDIAC MARKERS - RT & POC EUDAMEDW0102160701 CREATINE KINASE - MB MASS - RT & POC EUDAMEDW0102160702 MYOGLOBIN - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMEDBulgaria 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 Myoglobin/CK-MB-cTnI Combo 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-06936155804559 | 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 ba077d79-6d7a-43f5-8f24-fbe97a95f40e 61 fields · synced Jul 23, 2026
- EUDAMED 2f5326a1-6f6c-41ef-910d-266e1d490b7a 61 fields · synced Jul 9, 2026
- EUDAMED 0bad9791-6806-4bfd-86a3-05d69805e390 61 fields · synced Jul 10, 2026
- EUDAMED c663f599-e4c0-4fd9-b003-e7c2eddab35b 61 fields · synced Jul 23, 2026