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Nasal Pillow Mask

by Shenzhen SunnyGrand Healthcare Technology Co., Ltd. China EUDAMED

Ref AP01Model AP

EMDN R0301010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697434068APZT Basic UDI-DIDate31 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Nasal Pillow Mask
Model / Reference
AP, AP01
Primary DI / UDI-DI
06974340680335
Basic UDI-DI
697434068APZT
EMDN Code
R0301010201 Cpap masks
Device Class
Class IIa
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000017209
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Shenzhen SunnyGrand Healthcare Technology Co., Ltd.

See all devices from Shenzhen SunnyGrand Healthcare Technology 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 d495ba0c-d3c2-4f28-ac2e-dca35a32fc87 61 fields · synced 23 Oct 2026