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CO2 Mask

by Ningbo Shengyurui Medical Appliances Co., Ltd. China EUDAMED

Ref C0301-S6Model O2/CO2

EMDN R030199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69450993CPC001M4 Basic UDI-DIDate14 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN24/00007564 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 1639
    Issued
    5 Oct 2026
    Expires
    28 Nov 2029
    Reason
    Change approved

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
O2/CO2, C0301-S6
Primary DI / UDI-DI
06945099386380
Basic UDI-DI
69450993CPC001M4
EMDN Code
R030199 Respiratory masks - other
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000026643
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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 06945099386380|69450993CPC001M4 61 fields · synced 24 Oct 2026