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PURE O2 Stick

by Pure O2 Co. South Korea EUDAMED

Ref Pure-IFU-002Model PURE O2 Stick EMDN W0104010999

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08809628330078VD Basic UDI-DIDate31 Dec 2025RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Model / Reference
PURE O2 Stick, Pure-IFU-002
Primary DI / UDI-DI
08809628330078
Basic UDI-DI
08809628330078VD
Direct Marketing DI
08809628330078
EMDN Code
W0104010999 Environmental generating systems - other
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000050066
Authorised representative
SMGeurope OÜ EE-AR-000048466

Other devices from Pure O2 Co.

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 00d95c49-166b-4fca-b773-c6e718933973 61 fields · synced 22 Oct 2026