Skip to content

Mascarillas Quirúrgicas Con Gomas

by Feixi Hongwei Medical Devices Co., Ltd

Ref FMEB02Model 12.5*7CM; 14.5*9.5CM; 17.5*9.5CM; 20*7CM OR OTHER SIZE; WITH EAR-LOOP ELASTIC; WITH HEAD-LOOP ELASTIC; TIES-ON

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697491661FM007J2 Basic UDI-DI 06974916612180UDI-DIDate24 Mar 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  • Withdrawn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
disposable medical face mask
Model / Reference
12.5*7CM, 14.5*9.5CM, 17.5*9.5CM, 20*7CM OR OTHER SIZE, WITH EAR-LOOP ELASTIC, WITH HEAD-LOOP ELASTIC, TIES-ON, FMEB02
Primary DI / UDI-DI
06974916612180
Basic UDI-DI
697491661FM007J2
EMDN Code
T020604 Medical use face masks, type II and iir
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000033411
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Feixi Hongwei Medical Devices Co., Ltd

See all devices from Feixi Hongwei Medical Devices 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