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Flexy Two Lite / Two Layer Reduced Compression System

by Global Health and Safety Ltd

Ref 10367Model Flexy Bandages

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 Number506080741BDG001QS Basic UDI-DI 05060807412852UDI-DIDate22 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  • Withdrawn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

Model / Reference
Flexy Bandages, 10367
Primary DI / UDI-DI
05060807412852
Basic UDI-DI
506080741BDG001QS
EMDN Code
M030499 Elastic bandages, support and compression - other
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
UK-MF-000042285
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

From the manufacturer

Manufacturer's product page: Flexy Two Lite Reduced Compression System

Other devices from Global Health and Safety Ltd

See all devices from Global Health and Safety 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