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Decomics

by Diagnotis SAS France EUDAMED

Ref DEC010

EMDN W0105010799

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number3770032939DEC010SE Basic UDI-DIDate22 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
DEC010
Primary DI / UDI-DI
03770032939087
Basic UDI-DI
3770032939DEC010SE
EMDN Code
W0105010799 Mycobacteria reagents - other
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000035861

Other devices from Diagnotis SAS

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED db119b2b-983d-4431-9a1a-de12faa3eb2f 61 fields · synced 22 Oct 2026