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SafeMask Essential

by A.R.Medicom Inc. (Shanghai) Co. Ltd. China EUDAMED

Ref 2615 EMDN T020604

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number48944762615XZ Basic UDI-DIDate27 May 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  • Withdrawn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 · synced 23 Oct 2026

Device Name
Medical Face Mask TIIR
Model / Reference
2615
Primary DI / UDI-DI
03701407401137
Basic UDI-DI
48944762615XZ
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-000027545
Authorised representative
Medicom SAS FR-AR-000052994

Other devices from A.R.Medicom Inc. (Shanghai) 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 88a97cc2-04cc-4779-9909-1be390d590fa 61 fields · synced 23 Oct 2026