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Surgical mask Type IIR with earloops

by Suirsafe Technologies Ltd. EUDAMED

Active European Union

Ref SMTIIR-L

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberPP12054SMTIIR35177.29 Basic UDI-DIDate24 Nov 2021RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Surgical mask Type IIR
Model / Reference
SMTIIR-L
Primary DI / UDI-DI
111792003519
Basic UDI-DI
PP12054SMTIIR35177.29
Unit of Use DI
111792004182
EMDN Code
T020604 Medical use face masks, type II and iir
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000004594

Other devices from Suirsafe Technologies Ltd.

Properties

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