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PURE O2 Pack-Solid

by Pure O2 Co. South Korea EUDAMED

Ref Pure-IFU-001Model PURE O2 Pack-Solid

EMDN W0104010999

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08809628330061UU Basic UDI-DIDate31 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
PURE O2 Pack-Solid, Pure-IFU-001
Primary DI / UDI-DI
08809628330061
Basic UDI-DI
08809628330061UU
Direct Marketing DI
08809628330061
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 17343f8d-2c5d-47a3-924e-022d0ffb12e5 61 fields · synced 22 Oct 2026