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Medical Face mask

by Safeway Industry Healthcare

Ref Fack maskModel SW-03

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 Number697460179021032E Basic UDI-DI Date6 Dec 2021RegisteredStatusActive

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  • Withdrawn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
SW-03, Fack mask
Primary DI / UDI-DI
06974601790742, 06974601790728, 06974601792036
Basic UDI-DI
697460179021032E
Unit of Use DI
06974601790759, 06974601790735, 16974601792033
EMDN Code
T020604 Medical use face masks, type II and iir
Device Class
Class I
EU market of registration
Poland
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000001568
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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See all devices from Safeway Industry Healthcare →

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