Skip to content

LuvOn N2 Nasal Mask

by Heyer Care Co.，Ltd. EUDAMED

Active European Union

Ref 111500206Model AF-01, AF-02, AF-03, AN-01, AN-02, AN-03, AP-01, AH-01, AH-02

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  • Withdrawn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

Device Name
Breathing mask
Model / Reference
AF-01, AF-02, AF-03, AN-01, AN-02, AN-03, AP-01, AH-01, AH-02, 111500206
Primary DI / UDI-DI
06975384781996
Basic UDI-DI
697538478N00101CX
EMDN Code
R0301010201 Cpap masks
Device Class
Class IIa
Market of Registration
Sweden

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

Show properties
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