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Mycoprosafe

by SALUBRIS, Inc. United States EUDAMED

Ref TM240

EMDN W0105010799

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number08600111234TM240B2 Basic UDI-DIDate13 Dec 2023RegisteredStatusActive

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
TM240
Primary DI / UDI-DI
00860011123408
Basic UDI-DI
08600111234TM240B2
Direct Marketing DI
00860011123408
EMDN Code
W0105010799 Mycobacteria reagents - other
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
US-MF-000038921
Authorised representative
DIAGNOTIS SAS FR-AR-000038248

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 872ce71e-a6ec-4cdd-9035-9d7c84765de1 61 fields · synced 22 Oct 2026