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Medical face mask

by Wuhan DYMEX Healthcare Co., Ltd

Ref 17.5*9.5cmModel 12.5*8.5cm, 14.5*9.5cm, 17.5*9.5cm, 18.5*9.5cm, 16.5*9cm

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 Number697848081WHDM01XB Basic UDI-DI 06978480810034UDI-DIDate17 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  • Withdrawn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
Medical face mask
Model / Reference
12.5*8.5cm, 14.5*9.5cm, 17.5*9.5cm, 18.5*9.5cm, 16.5*9cm
Primary DI / UDI-DI
06978480810034
Basic UDI-DI
697848081WHDM01XB
EMDN Code
T020604 Medical use face masks, type II and iir
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000008966
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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