Identity
- Trade Name
- iFlash-hs-cTnI EUDAMED
- Device Name
- iFlash-hs-cTnI EUDAMED
- Model / Reference
- C86304 EUDAMEDC86305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925912719922 EUDAMED06925912720287 EUDAMED
- Basic UDI-DI
- 692591270266HR EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany 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
New Device
No
EUDAMED
iFlash-hs-cTnI by Shenzhen Yhlo Biotech Co., Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 692591270266HR | Class C | Active |
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Manufacturer
- Manufacturer
- Shenzhen Yhlo Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000001137
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 05d6a08e-dec6-4934-9410-2f1888805ea7 61 fields · synced Aug 1, 2026
- EUDAMED 8a0ea47b-565d-4c8c-b914-dafedce67bfc 61 fields · synced May 18, 2026