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LuvOn N2 Nasal Mask

by Heyer Care Co.，Ltd. China EUDAMED

Ref 111500257Model AF-01, AF-02, AF-03, AN-01, AN-02, AN-03, AP-01, AH-01, AH-02 EMDN R0301010201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697538478N00101CX Basic UDI-DIDate17 Apr 2026RegisteredStatusActive

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  • Withdrawn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 25 Oct 2026

Device Name
Breathing mask
Model / Reference
AF-01, AF-02, AF-03, AN-01, AN-02, AN-03, AP-01, AH-01, AH-02, 111500257
Primary DI / UDI-DI
06975384780326
Basic UDI-DI
697538478N00101CX
EMDN Code
R0301010201 Cpap masks
Device Class
Class IIa
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
CN-MF-000029617
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Heyer Care Co.，Ltd.

See all devices from Heyer Care Co.，Ltd. →

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 d9c73a92-1665-444b-8b79-905ce6af4f8e 61 fields · synced 25 Oct 2026