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In vitro Diagnostic Kit for High sensitivity Troponin T (Chemiluminescence Assa…
EUDAMEDClass IVD General (EU MDR)
Ref 1CTNTB12
Identity
- Trade Name
- In vitro Diagnostic Kit for High sensitivity Troponin T (Chemiluminescence Assay) EUDAMED
- Device Name
- In vitro Diagnostic Kit for High sensitivity Troponin T (Chemiluminescence Assay) EUDAMED
- Model / Reference
- 1CTNTB12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950996004381 EUDAMED
- Basic UDI-DI
- B-06950996004381 EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
In vitro Diagnostic Kit for High sensitivity Troponin T (Chemiluminescence Assa… by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD General — IVDD — listed…
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-06950996004381 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 80dfe57d-14e0-4234-9412-1b9a88f5cf4b 61 fields · synced Jun 19, 2026