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Oxygen

by Medicom SAS EUDAMED

Active European Union

Ref M52014-WH-MB, M52214-WH-MB, M52014S-WH-MB, M52214S-WH-MB, M53014-WH-MB, M51014S-WH-MB, M52014S-WHModel TIIR & FFP2 NR D Mask, TIIR & FFP3 NR D Mask

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number37014074MAIIR47AX Basic UDI-DIDate10 Feb 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  • Withdrawn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

Model / Reference
TIIR & FFP2 NR D Mask, M52014-WH-MB, M52214-WH-MB, M52014S-WH-MB, M52214S-WH-MB, TIIR & FFP3 NR D Mask, M53014-WH-MB, M51014S-WH-MB, M52014S-WH
Primary DI / UDI-DI
03662036020536, 03662036020499, 03662036020550, 03662036020512, 03662036020659, 03662036022677, 03662036018229
Basic UDI-DI
37014074MAIIR47AX, 37014074MAIIR52AQ
EMDN Code
T020604 Medical use face masks, type ii and iir
Device Class
Class I
Market of Registration
France
Denmark

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