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High Sensitivity Cardiac Troponin I Rapid Test Device - plasma
EUDAMEDClass IVD General (EU MDR)
Ref E020501D
Identity
- Trade Name
- High Sensitivity Cardiac Troponin I Rapid Test Device (whole blood/serum/plasma) EUDAMED
- Model / Reference
- E020501D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976753472774 EUDAMED
- Basic UDI-DI
- B-06976753472774 EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T EUDAMED
- Models / Variants
- whole blood EUDAMEDserum EUDAMEDplasma EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
High Sensitivity Cardiac Troponin I Rapid Test Device - plasma by Hangzhou Cybereagen Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — 3…
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-06976753472774 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Cybereagen Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000037850
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 10e8f79b-298b-47ea-a1a6-14a4bace85e0 61 fields · synced Oct 6, 2026