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Mesh Nebulizer

by Shenzhen Fitconn Technology Co., ltd China EUDAMED

Ref MY-132, MY-130, MY-123B, MY-135, MY-130BModel MY-123, MY-130, MY-132, MY-133, MY-135, MY-123B, MY-130B, MY-132B, MY 133B, MY-135B EMDN Z12040210

Regulatory status

as of 26 Oct 2026

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

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  • Withdrawn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)
  • FI26/1008022 Supplemented

    Quality management system EU MDR

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

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
MY-123, MY-130, MY-132, MY-133, MY-135, MY-123B, MY-130B, MY-132B, MY 133B, MY-135B
Primary DI / UDI-DI
06970470480692, 06970470480753, 06970470480623, 06970470480678, 06970470480630
Basic UDI-DI
697047048MYNEBQ8
Direct Marketing DI
06970470480692
06970470480753
06970470480623
06970470480678
06970470480630
EMDN Code
Z12040210 Ultrasonic nebulisers
Device Class
Class IIa
Market of Registration
Italy
Belgium
Austria
Bulgaria

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 & 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 (5)

  • EUDAMED 698cc113-50a8-4277-b8f2-b13d3d57c19b 61 fields · synced 22 Oct 2026
  • EUDAMED 06970470480753|697047048MYNEBQ8 61 fields · synced 11 May 2026
  • EUDAMED 06970470480623|697047048MYNEBQ8 61 fields · synced 17 May 2026
  • EUDAMED 06970470480678|697047048MYNEBQ8 61 fields · synced 17 May 2026
  • EUDAMED 06970470480630|697047048MYNEBQ8 61 fields · synced 18 May 2026