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Cardiac Troponin I Rapid Test Device(Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref D070216D
Identity
- Trade Name
- Cardiac Troponin I Rapid Test Device(Colloidal Gold) EUDAMED
- Model / Reference
- D070216D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971792053991 EUDAMED
- Basic UDI-DI
- B-06971792053991 EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T 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
Cardiac Troponin I Rapid Test Device(Colloidal Gold) by Hangzhou Realy Tech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06971792053991 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Realy Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000004716
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 13b42281-9d0d-45cc-8396-f206ab564a20 61 fields · synced Jun 19, 2026