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Medical Air/Oxygen Blender

by Ningbo David Medical Device Co., Ltd. 2 variants

Ref KY-20B, KY-30BModel KY-10B/KY-20B/KY-30B

Active European Union

CE MDR CE MDD

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 NumberB-06920716303513 Basic UDI-DI Date23 May 2024RegisteredStatusActive
European UnionCE/MDD NumberB-06920716303513 Basic UDI-DI Date23 May 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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Model / Reference
KY-20B, KY-30B, KY-10B/KY-20B/KY-30B
Primary DI / UDI-DI
06920716303513, 06920716303537
Basic UDI-DI
B-06920716303513, B-06920716303537, 69207163KY-001EH
Direct Marketing DI
06920716303513
06920716303537
EMDN Code
Z12159004 Oxygen concentrators
Device Class
Class IIb
EU market of registration
Italy
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000009962
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Ningbo David Medical Device Co., Ltd.

See all devices from Ningbo David 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