EUDAMED device

QUANTA Flash

EUDAMED device 00195126000109 · Inova Diagnostics. Inc.

Key facts

Primary DI 00195126000109
Trade name QUANTA Flash
Device name QUANTA Flash® Circulating Calprotectin Controls
Reference or catalog number 701367
Manufacturer Inova Diagnostics. Inc.
Manufacturer SRN US-MF-000017851
Risk class IVD General
EMDN code W0102152011
EMDN description CONTROLS FOR AUTOIMMUNITY
Legislation ivdd
Implantable No
Sterile No
Single use Yes
Status date Dec 17, 2025

At a glance

  • No Matching FDA GUDID record

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About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

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