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Ultra-Quiet Portable Nebulizers

by Shenzhen Fitconn Technology Co., ltd 6 variants

Ref 100002420Model MY-123, MY-130, MY-132, MY-133, MY-135, MY-123B, MY-130B, MY-132B, MY 133B, MY-135B

Active European Union

CE MDR

Valid until

16 Apr 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS FIMKO OY

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberFI26/1008022 Date1 Jul 2026IssuedStatusActive expires 16 Apr 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • FI26/1008022 Active Supplemented

    Quality management system EU MDR

    Certifier
    SGS FIMKO OY 0598
    Issued
    1 Jul 2026
    Expires
    16 Apr 2031
    Reason
    Other

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Mesh Nebulizer
Model / Reference
MY-123, MY-130, MY-132, MY-133, MY-135, MY-123B, MY-130B, MY-132B, MY 133B, MY-135B, 100002420
Primary DI / UDI-DI
01220000227200
Basic UDI-DI
697047048MYNEBQ8
Direct Marketing DI
01220000227200
EMDN Code
Z12040210 Ultrasonic nebulisers
Device Class
Class IIa
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000024538
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Shenzhen Fitconn Technology Co., ltd

See all devices from Shenzhen Fitconn Technology Co., ltd →

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