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SureflO2 Flow Indicator Oxygen Mask

by SureflO2 Trading Pty Ltd EUDAMED

Active European Union

Ref SF02-MA01

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-936900029995GS Basic UDI-DIDate12 Feb 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
SureflO2 Flow Indicator Oxygen Mask
Model / Reference
SF02-MA01
Primary DI / UDI-DI
D-936900029995GS
Basic UDI-DI
B-936900029995GS
EMDN Code
R030199 Respiratory masks - other
Device Class
Class IIa
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
AU-MF-000045991
Authorised representative
Compliance Management Solutions Europe LTD BG-AR-000020809

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No