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FloQuant™ Fluorescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref SAAFIA-01
Identity
- Trade Name
- FloQuant™ Fluorescence Immunoassay Analyzer EUDAMED
- Device Name
- FloQuant™ Fluorescence Immunoassay Analyzer EUDAMED
- Model / Reference
- SAAFIA-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08905459007025 EUDAMED
- Basic UDI-DI
- 8905459FLOQB3 EUDAMED
- EMDN Code
- W0201020201 IMMUNOCHEMISTRY READERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Bulgaria 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
FloQuant™ Fluorescence Immunoassay Analyzer by Meril Diagnostics Pvt. 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 | 8905459FLOQB3 | Class A | Active |
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Manufacturer
- Manufacturer
- Meril Diagnostics Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000028158
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED b7b92b8a-7aaa-4ecc-9cbc-29f657976c42 61 fields · synced Jul 9, 2026