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Nebulizer Kit

by AOJ HEALTH Technology Co., Ltd. 4 variants

Ref NEK-Mini-01Model NEK-01, NEK-Mini-01, AeroJet-01, AeroJet-Mini-01

Active European Union

CE MDR

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697631375NEKXQN Basic UDI-DI 06976313751219UDI-DIDate20 Aug 2026RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Model / Reference
NEK-01, NEK-Mini-01, AeroJet-01, AeroJet-Mini-01
Primary DI / UDI-DI
06976313751219
Basic UDI-DI
697631375NEKXQN
Direct Marketing DI
06976313751219
EMDN Code
R060101 Cold nebulisation systems
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000037449
Authorised representative
Share info GmbH DE-AR-000005132

Other devices from AOJ HEALTH Technology Co., Ltd.

See all devices from AOJ HEALTH Technology Co., Ltd. →

Properties

  • Reusable
  • Administering Medicine

Other properties (11)

  • Sterile: No
  • Implantable: 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