Identity
- Trade Name
- TnI (CLIA) EUDAMED
- Device Name
- TnI (CLIA) EUDAMED
- Model / Reference
- MCL01602E EUDAMEDMCL01601E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802603208 EUDAMED06926802603192 EUDAMED
- Basic UDI-DI
- B-06926802603208 EUDAMEDB-06926802603192 EUDAMED69268026MD71A00001TQ EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
New Device
No
EUDAMED
TnI (CLIA) by Medcaptain Medical Technology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06926802603208 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06926802603208 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Medcaptain Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005925
- Authorised Representative
- R Sight B.V. NL-AR-000010445
Sources (4)
- EUDAMED 97671ead-16d9-489a-bb82-c8a1a335f7a7 61 fields · synced Jul 28, 2026
- EUDAMED 77904eac-7a2c-4f7e-a4d1-f6ba883493cc 61 fields · synced May 18, 2026
- EUDAMED 8d187faf-d706-475f-995f-494c6b10db62 61 fields · synced Jun 18, 2026
- EUDAMED 79694c79-2998-4793-af5a-57a14967fac6 61 fields · synced Jul 28, 2026