Skip to content

MycoDDR Trident Mycobacterium Digestion and Decontamination Reagent Sets

by IMMY, Inc.

Ref TBNN1010-3.0

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number081638702MycoNF Basic UDI-DI 00816387021053UDI-DIDate3 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Mycobacterium Digestion and Decontamination Reagent Sets
Model / Reference
TBNN1010-3.0
Primary DI / UDI-DI
00816387021053
Basic UDI-DI
081638702MycoNF
Direct Marketing DI
00816387021053
EMDN Code
W0105010799 Mycobacteria reagents - other
Device Class
Class A
EU market of registration
France

Manufacturer details

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

Other devices from IMMY, Inc.

Properties

  • Reagent
  • Professional Testing
  • New Device

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No