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Breeze Endotracheal Tube Holder -Standard

by Insight Medical Products Ltd

Ref TFP/200

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 Number506041364TF005V1U6 Basic UDI-DI 05060413640540UDI-DIDate17 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Breeze Endotracheal Tube Holder
Model / Reference
TFP/200
Primary DI / UDI-DI
05060413640540
Basic UDI-DI
506041364TF005V1U6
Unit of Use DI
25060413640544
EMDN Code
R01038099 Endotracheal tubes - accessories not included in other classes
Device Class
Class I
EU market of registration
Malta

Manufacturer details

EUDAMED SRN
GB-MF-000004395
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Insight Medical Products Ltd

See all devices from Insight Medical Products Ltd →

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