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Vivid Advanced, Vivid Focus

by GE Vingmed Ultrasound AS

Ref Vivid Focus X v211 / TC001006Model Vivid Explorer, Vivid Advanced, Vivid Focus

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08406821BUG0061173 Basic UDI-DI 00198953040270UDI-DIDate11 Aug 2025RegisteredStatusActive

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  • Withdrawn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
Vivid Explorer, Vivid Advanced, Vivid Focus
Model / Reference
Vivid Explorer, Vivid Advanced, Vivid Focus, Vivid Focus X v211 / TC001006
Primary DI / UDI-DI
00198953040270
Basic UDI-DI
08406821BUG0061173
Direct Marketing DI
00198953040270
EMDN Code
Z11040102 Cardiology ultrasound scanners
Device Class
Class IIa
EU market of registration
Norway

Manufacturer details

EUDAMED SRN
NO-MF-000000553

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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