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Pocket Ultrasound System

by WuHan Youkey Bio-Medical Electronics Co., Ltd. 2 variants

Ref Included are following Pocket Ultrasound Probes (model: C5-2Ks, L11-4Ks, L11-4Gs, C8-5Ks)Model D8, D8(Included are following Pocket Ultrasound Probes (model: C5-2Ks, L11-4Ks, L11-4Gs,C8-5Ks))

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-06977793420008 Basic UDI-DI 06977793420008UDI-DIDate27 Mar 2026RegisteredStatusActive
European UnionCE/MDD NumberB-06977793420008 Basic UDI-DI 06977793420008UDI-DIDate27 Mar 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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Model / Reference
D8, Included are following Pocket Ultrasound Probes (model: C5-2Ks, L11-4Ks, L11-4Gs, C8-5Ks), D8(Included are following Pocket Ultrasound Probes (model: C5-2Ks, C8-5Ks))
Primary DI / UDI-DI
06977793420008
Basic UDI-DI
B-06977793420008, 6977793421000D852
Direct Marketing DI
06977793420008
EMDN Code
Z11040103 Portable ultrasound scanners
Device Class
Class IIa
EU market of registration
Germany
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000036468
Authorised representative
Share info GmbH DE-AR-000005132

Other devices from WuHan Youkey Bio-Medical Electronics Co., Ltd.

See all devices from WuHan Youkey Bio-Medical Electronics Co., Ltd. →

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No