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Sleep Apnoea Breathing Therapy Device

by Shenzhen SunnyGrand Healthcare Technology Co., Ltd. EUDAMED

Active European Union

Ref NatrRes SVAP PlusModel NatrMeet, NatrSleep, NatrRes

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberFI23/1008003 Date27 Sep 2025IssuedStatusActive expires 23 Oct 2028

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • FI23/1008003 Supplemented

    Quality management system EU MDR

    Notified body
    SGS FIMKO OY 0598
    Issued
    27 Sep 2025
    Expires
    23 Oct 2028
    Reason
    Other

Specification

EUDAMED

Device Name
Sleep Apnoea Breathing Therapy Device
Model / Reference
NatrMeet, NatrSleep, NatrRes, NatrRes SVAP Plus
Primary DI / UDI-DI
06974340680830
Basic UDI-DI
697434068A101&A111WW
Direct Marketing DI
06974340680830
Market of Registration
Iceland

Manufacturer details

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

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