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Omnimask Antifog

by Medicom SAS EUDAMED

Active European Union

Ref 116520, 116528, 116530, 116529

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number37014074MAIIR08AM Basic UDI-DIDate10 Jan 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
Medical Face Mask TIIR
Model / Reference
116520, 116528, 116530, 116529
Primary DI / UDI-DI
03662036015730, 03701407400796, 03701407400758, 03701407400772
Basic UDI-DI
37014074MAIIR08AM
EMDN Code
T020604 Medical use face masks, type ii and iir
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
FR-MF-000002873

Other devices from Medicom SAS

See all devices from Medicom SAS →

Properties

Show properties
  • Animal Tissues
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No