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Ultrasonic Nebulizer

by Elmaslar İmalat Tibbi̇ Ci̇hazlar İnş. Taş.i̇th.i̇hr.san. Ve Ti̇c.a.ş.

Ref KT08Model NEBTIME UN600A, NEBTIME UN300A, NEBTIME UN700, FLEXOR UN01, SKYCELL UN01, FLYMIST UN01, UPWELL UN01, ELİTE UN01

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-UN99 Basic UDI-DIDate14 Oct 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Ultrasonic Nebulizer
Model / Reference
NEBTIME UN600A, NEBTIME UN300A, NEBTIME UN700, FLEXOR UN01, SKYCELL UN01, FLYMIST UN01, UPWELL UN01, ELİTE UN01, KT08
Primary DI / UDI-DI
D-UN99
Basic UDI-DI
B-UN99
EMDN Code
Z12040210 Ultrasonic nebulisers
Device Class
Class IIa
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000030191

Other devices from Elmaslar İmalat Tibbi̇ Ci̇hazlar İnş. Taş.i̇th.i̇hr.san. Ve Ti̇c.a.ş.

Properties

  • Administering Medicine

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No