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Voluson Signature 16

by GE Ultrasound Korea, Ltd.

Ref Voluson Signature 16 BT27 / 5994028Model Voluson Signature 20, Voluson Signature 18, Voluson Signature 16

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 Number8406821BUG00309HD Basic UDI-DI 00198953121375UDI-DIDate12 Jun 2023RegisteredStatusActive

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  • Withdrawn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
Voluson Signature 20, Voluson Signature 18, Voluson Signature 16
Model / Reference
Voluson Signature 20, Voluson Signature 18, Voluson Signature 16, Voluson Signature 16 BT27 / 5994028
Primary DI / UDI-DI
00198953121375
Basic UDI-DI
8406821BUG00309HD
EMDN Code
Z11040101 Internal ultrasound scanners
Device Class
Class IIa
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
KR-MF-000001860
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Other devices from GE Ultrasound Korea, Ltd.

See all devices from GE Ultrasound Korea, 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