Skip to content

Colorex Strep a

by Mascia Brunelli S.p.A. Italy EUDAMED

Ref 54SP37Model COLOREX

EMDN W0104010402

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number80579988COLOREXPLATE5Z Basic UDI-DIDate16 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
COLOREX, 54SP37
Primary DI / UDI-DI
08057998876058
Basic UDI-DI
80579988COLOREXPLATE5Z
EMDN Code
W0104010402 Chromogenic id media (plates)
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000009572

Other devices from Mascia Brunelli S.p.A.

See all devices from Mascia Brunelli S.p.A. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 08057998876058|80579988COLOREXPLATE5Z 61 fields · synced 24 Oct 2026