Identity
- Trade Name
- QUANTA Flash EUDAMED
- Device Name
- QUANTA Flash® Circulating Calprotectin Reagents EUDAMED
- Model / Reference
- 701365 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00195126000086 EUDAMED
- Basic UDI-DI
- B-00195126000086 EUDAMED
- EMDN Code
- W0102019009 CALPROTECTIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
QUANTA Flash by Inova Diagnostics, Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-00195126000086 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Inova Diagnostics. Inc.
- EUDAMED SRN
- US-MF-000017851
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED f0993d4e-283c-4ea6-8338-510cb052b28c 61 fields · synced May 29, 2026