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VOC-IMO-Testkit

by VOC-Advanced Breath Diagnostics GmbH

Ref VOC-IMO-001

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4170000VOC-IMO-001FL Basic UDI-DI 04170000250272UDI-DIDate10 Sep 2025RegisteredStatusActive

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  • Withdrawn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

Model / Reference
VOC-IMO-001
Primary DI / UDI-DI
04170000250272
Basic UDI-DI
4170000VOC-IMO-001FL
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000048809

Other devices from VOC-Advanced Breath Diagnostics GmbH

Properties

  • Self Testing
  • New Device

Other properties (9)

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