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Medical Face Mask

by Hainan Fosun Medical Trade Limited Company

Ref NL-CA002-2021-63653Model Ear Loop、Tie-on Band

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697505426213FSFM17U Basic UDI-DI 06975054266242UDI-DIDate25 May 2023RegisteredStatusActive

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  • Withdrawn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 Masks
Model / Reference
Ear Loop、Tie-on Band, NL-CA002-2021-63653
Primary DI / UDI-DI
06975054266242
Basic UDI-DI
697505426213FSFM17U
Direct Marketing DI
06975054266242
EMDN Code
T020604 Medical use face masks, type II and iir
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000022779
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hainan Fosun Medical Trade Limited Company

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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