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Mycobacterium Digestion and Decontamination Reagent Sets

by IMMY, Inc. EUDAMED

Active European Union

Ref TBRP30-60

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number081638702MycoNF Basic UDI-DIDate3 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Mycobacterium Digestion and Decontamination Reagent Sets
Model / Reference
TBRP30-60
Primary DI / UDI-DI
00816387021138
Basic UDI-DI
081638702MycoNF
Direct Marketing DI
00816387021138
EMDN Code
W0105010799 Mycobacteria reagents - other
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
US-MF-000025165
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from IMMY, Inc.

Properties

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