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Facemask

by Hygiea Medical Technology (Beijing) Co., Ltd.

Ref HMFMEL01, HMFMEL02, HMFMTB01, HMFMTB02Model HMFMEL01

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 Number697633971FacemaskSN Basic UDI-DI 16976339710488UDI-DIDate5 Apr 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  • Withdrawn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
Face mask
Model / Reference
HMFMEL01, HMFMEL02, HMFMTB01, HMFMTB02
Primary DI / UDI-DI
16976339710488
Basic UDI-DI
697633971FacemaskSN
EMDN Code
T020604 Medical use face masks, type II and iir
Device Class
Class I
EU market of registration
Latvia

Manufacturer details

EUDAMED SRN
CN-MF-000041007
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hygiea Medical Technology (Beijing) Co., Ltd.

See all devices from Hygiea Medical Technology (Beijing) 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