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FISIO CHAMBER TRIGON Anti-static inhaler chamber for MDI with Fisio mask and carrying bag

by Koo (Shanghai) Industries Co., Ltd.

Ref KM-1033B

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, self-declared

Class I: no certifier involved

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 Number697038423K2GNY Basic UDI-DI 16970384237228UDI-DIDate17 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Fisiojet Line
Model / Reference
KM-1033B
Primary DI / UDI-DI
16970384237228
Basic UDI-DI
697038423K2GNY
EMDN Code
R0680 Nebulisation and humidification systems - accessories not included in other classes
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000045584
Authorised representative
KOO EUROPE IT-AR-000030005

Other devices from Koo (Shanghai) Industries Co., Ltd

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Properties

Other properties (13)

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