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Surgical masks Type IIR with loops

by Feixi Hongwei Medical Devices Co., Ltd China EUDAMED

Ref FMT2RModel 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 EMDN T020604

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697491661FM007J2 Basic UDI-DIDate24 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

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, FMT2R
Primary DI / UDI-DI
06974916611169
Basic UDI-DI
697491661FM007J2
EMDN Code
T020604 Medical use face masks, type ii and iir
Device Class
Class I
Market of Registration
France

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 & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 8e4205ba-2ea1-4aab-a920-21c6c2534a78 61 fields · synced 22 Oct 2026