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Face Guard Type II

by Global Health and Safety Ltd

Ref FGMSM101205Model Type II and Type IIR Series

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 Number506080741MSM0013T Basic UDI-DI 05060807410223UDI-DIDate7 Nov 2024RegisteredStatusActive

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  • Withdrawn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
Surgical Mask
Model / Reference
Type II and Type IIR Series, FGMSM101205
Primary DI / UDI-DI
05060807410223
Basic UDI-DI
506080741MSM0013T
EMDN Code
T020604 Medical use face masks, type II and iir
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: Faceguard

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