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Omnimask Comfort

by Medicom SAS EUDAMED

Active European Union

Ref 118863

Overview

The Omnimask Comfort medical face mask is a highly effective and convenient solution for patients with sensitive skin. This device features advanced AR technology, allowing users to precisely apply the mask without compromising their health.

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  • Withdrawn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
118863
Primary DI / UDI-DI
03662036016034
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