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Face mask (Nonwoven Face mask, Activated carbon face mask, Anti-dust mask, Cup shaped mask, face mask with plastic shield, Dust mask, Paper face mask, 3D face mask)

by One Top Protective Products Co., Ltd.

Ref FACE MASK EarloopModel Earloop, Ties,Headloop

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697867649FM01UM Basic UDI-DI 06978676491702UDI-DIDate11 Jun 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  • Withdrawn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

Model / Reference
Earloop, Ties, Headloop, FACE MASK Earloop
Primary DI / UDI-DI
06978676491702
Basic UDI-DI
697867649FM01UM
EMDN Code
T020699 Medical use face masks (excluding personal protective equipment - PPE) - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000023063
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from One Top Protective Products Co., Ltd.

See all devices from One Top Protective Products Co., 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