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Buchanan Lite Protectors Large Black

by Sheffmed Limited 2 variants

Ref LABLT2004

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506041720PROTECTOR-SU53 Basic UDI-DI 05060417204687UDI-DIDate16 Apr 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Tracheostoma Protective Filters Buchanan Buchanan Lite Buchanan Deltanex Laryngofoam
Model / Reference
LABLT2004
Primary DI / UDI-DI
05060417204687
Basic UDI-DI
506041720PROTECTOR-SU53
EMDN Code
R01058002 Tracheostomy filters
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
GB-MF-000004158
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Sheffmed Limited

See all devices from Sheffmed 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