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oxygen concentrator

by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. 5 variants

Ref 7F-10, 8F-2AModel 8F-1A/8F-2A

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number693325792231HR Basic UDI-DIDate24 Apr 2024RegisteredStatusActive

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  • Withdrawn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

Device Name
oxygen concentrator
Model / Reference
7F-10, 8F-1A/8F-2A, 8F-2A
Primary DI / UDI-DI
06933257922310, 06933257922297
Basic UDI-DI
693325792231HR, 693325792229J6
Direct Marketing DI
06933257922310
06933257922297
EMDN Code
Z12159004 Oxygen concentrators
Device Class
Class IIb
Market of Registration
Türkiye
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000012834
Authorised representative
Metrax GmbH DE-AR-000005481

Other devices from Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

See all devices from Jiangsu Yuyue Medical Equipment & Supply 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