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JLO-590Si, Galena

by Shenzhen Homed Medical Device Co., Ltd.

Ref 06956937003383, 06956937003352, 06956937003369Model JLO-390i、JLO-390Si、JLO-590i、JLO-590Si、JLO-1090Si、JLO-190i、JLO-190P

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69569370HOMED00002Z6 Basic UDI-DI Date24 Apr 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  • Withdrawn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

Trade Name
JLO-590Si,Galena
JLO-390i
JLO-390Si
Device Name
Oxygen Concentrator
Model / Reference
JLO-390i、JLO-390Si、JLO-590i、JLO-590Si、JLO-1090Si、JLO-190i、JLO-190P, 06956937003383, 06956937003352, 06956937003369
Primary DI / UDI-DI
06956937003383, 06956937003352, 06956937003369
Basic UDI-DI
69569370HOMED00002Z6
Direct Marketing DI
06956937003383
06956937003352
06956937003369
EMDN Code
Z12159004 Oxygen concentrators
Device Class
Class IIb
EU market of registration
Türkiye
Austria

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

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