Skip to content

Portable (Ultrasonic) Nebulizer

by Dongguan SIMZO Electronic Technology Co., Ltd. 26 variants

Ref NBM-12

Active European Union

CE MDR

Valid until

6 Mar 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberCN25/00001354 Date26 May 2026IssuedStatusActive expires 6 Mar 2030

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN25/00001354 Active Supplemented

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    26 May 2026
    Expires
    6 Mar 2030
    Reason
    Change approved

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
NBM-12
Primary DI / UDI-DI
06959989130748
Basic UDI-DI
69599891XZNEB0001KC
Direct Marketing DI
06959989130748
EMDN Code
Z12040210 Ultrasonic nebulisers
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000015642
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Dongguan SIMZO Electronic Technology Co., Ltd.

See all devices from Dongguan SIMZO Electronic Technology Co., Ltd. →

Properties

  • Administering Medicine

Other properties (12)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No