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Nebulon Piston Compressor Nebulizer

by Shenzhen Homed Medical Device Co., Ltd. EUDAMED510(k)

Active European Union and United States

Ref Directive 93/42/EEC on Medical Devices, 06956937002942Model JLN-2300AIR

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-09506000117843 Basic UDI-DIDate2 Jul 2024RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-09506000117843 Basic UDI-DIDate2 Jul 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK212395 Date25 Mar 2022IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · 510(k)

Trade Name
Nebulon Piston Compressor Nebulizer
JLN-2300Air EVOLU UNIVERSAL PISTON COMPRESOR nebulizer
Device Name
Piston Compressor Nebulizer
Model / Reference
JLN-2300AIR, Directive 93/42/EEC on Medical Devices, 06956937002942
Primary DI / UDI-DI
09506000117843, 06956937002942
Basic UDI-DI
B-09506000117843, 69569370HOMED00001Z4
Direct Marketing DI
06956937002942
EMDN Code
R060101 Cold nebulisation systems
Device Class
Class IIa
Market of Registration
Cyprus
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000016463
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Homed Medical Device Co., Ltd.

See all devices from Shenzhen Homed Medical Device Co., Ltd. →

Properties

  • Administering Medicine NoEUDAMEDYesEUDAMED

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