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Classic Halo Chin Strap

by Foxxmed Ltd

Ref FMMD2063

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 Number471987636FMDHEADGEAR7J Basic UDI-DI 04719876361226UDI-DIDate14 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  • Withdrawn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
Chin Strap
Model / Reference
FMMD2063
Primary DI / UDI-DI
04719876361226
Basic UDI-DI
471987636FMDHEADGEAR7J
EMDN Code
R030180 Respiratory masks - accessories not included in other classes
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000022145
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Foxxmed Ltd

See all devices from Foxxmed 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