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Nebulizing Systems (Compressor)

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

Ref K15Model NEBTIME (CN01, CN02, CN03, CN04), ELİTE (KN01, KN02, KN03, KN04), FLEXOR (KN01, KN02, KN03, KN04), VEDEXA (KN01, KN02, KN03, KN04), SKYCELL (KN01, KN02), FLYMIST (KN01, KN02), UPWELL (KN01, KN02)

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-CN7K Basic UDI-DIDate11 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  • Withdrawn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
Nebulizing Systems (Compressor)
Model / Reference
NEBTIME (CN01, CN02, CN03, CN04), ELİTE (KN01, KN02, KN03, KN04), FLEXOR (KN01, VEDEXA (KN01, SKYCELL (KN01, KN02), FLYMIST (KN01, UPWELL (KN01, K15
Primary DI / UDI-DI
D-CN7K
Basic UDI-DI
B-CN7K
EMDN Code
R060101 Cold nebulisation systems
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

Other properties (11)

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