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Op Air One

by Medicom SAS EUDAMED

Active European Union

Ref M34101M-30

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number37014074MAIIR11AA Basic UDI-DIDate19 Feb 2026RegisteredStatusActive

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  • Withdrawn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
M34101M-30
Primary DI / UDI-DI
03662036013446
Basic UDI-DI
37014074MAIIR11AA
EMDN Code
T020604 Medical use face masks, type ii and iir
Device Class
Class I
Market of Registration
Portugal

Manufacturer details

EUDAMED SRN
FR-MF-000002873

Other devices from Medicom SAS

See all devices from Medicom SAS →

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