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iFlash 9000 CLIA Analyzer
EUDAMEDClass A (EU MDR)
Ref FG0076Model iFlash 9000-A
Identity
- Device Name
- iFlash 9000 CLIA Analyzer EUDAMED
- Model / Reference
- iFlash 9000-A EUDAMEDFG0076 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925912715245 EUDAMED
- Basic UDI-DI
- 692591270180HE EUDAMED
- EMDN Code
- W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
iFlash 9000 CLIA Analyzer by Shenzhen Yhlo Biotech Co., Ltd. — Class A — 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 | 692591270180HE | Class A | 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 (1)
- EUDAMED f454166e-507c-4183-aab9-4dc7e402c711 61 fields · synced Jun 20, 2026