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Disposable Medical Face Mask

by Hubei Sunrise Protective Products Co., Ltd 2 variants

Ref 17.5*9.5CM，3ply ear loopModel 17.5*9.5CM，3ply ear loop;17.5*9.5CM，3ply with ties

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 Number697661482Mask001R9 Basic UDI-DI Date12 May 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  • Withdrawn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
17.5*9.5CM，3ply ear loop, 17.5*9.5CM，3ply with ties
Primary DI / UDI-DI
16976614820017, 06976614820010
Basic UDI-DI
697661482Mask001R9
EMDN Code
T020604 Medical use face masks, type II and iir
Device Class
Class I
EU market of registration
Greece
France

Manufacturer details

EUDAMED SRN
CN-MF-000026235
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hubei Sunrise Protective Products Co., Ltd

See all devices from Hubei Sunrise 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