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QUANTA Flash

by Inova Diagnostics. Inc. United States EUDAMED

Ref 701221

EMDN W0102152211

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08426950627807 Basic UDI-DIDate18 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
QUANTA Flash® CTD Screen Plus Calibrators
Model / Reference
701221
Primary DI / UDI-DI
08426950627807
Basic UDI-DI
B-08426950627807
EMDN Code
W0102152211 Standards and calibrators for autoimmunity
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
US-MF-000017851
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Inova Diagnostics, Inc.

See all devices from Inova Diagnostics, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 162dbdf3-9b27-4c6d-9f6d-2d0778010a99 61 fields · synced 24 Oct 2026