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Voluson Expert 18 BT27

by GE Healthcare Austria GmbH & Co OG

Ref Voluson Expert 18 BT27

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00198953083253 UDI-DI Date9 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8406821BUG00372HL Basic UDI-DI 00198953083253UDI-DIDate20 Sep 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Voluson Expert 18 BT27 EUDAMED
Voluson GUDID
Generic Name
General-purpose ultrasound imaging system
Device Name
Voluson Expert 18, Voluson Expert 20, Voluson Expert 22
Model / Ref / Catalog
Voluson Expert 18 BT27 EUDAMED
Expert 18 BT27 GUDID
5975256 GUDID
Primary DI / UDI-DI
00198953083253
Basic UDI-DI
8406821BUG00372HL
Direct Marketing DI
00198953083253
510(k) Number
FDA Product Code
ITX, IYN, IYO, QIH
EMDN Code
Z11040104 Multidisciplinary ultrasound scanners (internal and cardiology, etc.)
GMDN Term
General-purpose ultrasound imaging system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1570, 892.1550, 892.1560, 892.2050
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Voluson Expert 18 BT27
GUDID
Expert 18 BT27
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
AT-MF-000001461

Other devices from GE Healthcare Austria GmbH & Co OG

See all devices from GE Healthcare Austria GmbH & Co OG →

Properties

  • Measuring Function
  • Prescription Use
  • Serial Number

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No