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Breath Trainer

by Flexicare Medical Limited 2 variants

Ref 8-402

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 Number5055788700015301GV Basic UDI-DI 05055931131267UDI-DIDate20 May 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  • Withdrawn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
Breath Trainer
Model / Reference
8-402
Primary DI / UDI-DI
05055931131267
Basic UDI-DI
5055788700015301GV
EMDN Code
Z1203019080 Various instruments for anaesthesia and pulmonary ventilation support - hardware accessories
Device Class
Class I
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000034163
Authorised representative
Flexicare EU Ops Ltd XI-AR-000048902

Other devices from Flexicare Medical Limited

See all devices from Flexicare Medical 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