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SafeBreath (Box of 50)

by MD Diagnostics Ltd

Ref FM50

Active European Union

CE MDR

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/MDR Number506043581CDMP5P Basic UDI-DI 05060435810310UDI-DIDate19 Oct 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
SafeBreath Bacterial Viral Mouthpiece (Box 50)
Model / Reference
FM50
Primary DI / UDI-DI
05060435810310
Basic UDI-DI
506043581CDMP5P
EMDN Code
Z1399 Non-specific consumables for diagnostic instruments - other
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
UK-MF-000049022
Authorised representative
CS Life Sciences Europe Ltd IE-AR-000004113

Other devices from MD Diagnostics Limited

See all devices from MD Diagnostics Limited →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No