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Vivid E v203 v204 to v206 UPG

by GE Vingmed Ultrasound AS

Ref Vivid E v203 v204 to v206 UPGModel Vivid E95_Vivid E90_Vivid E80

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 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00195278516343 UDI-DI Date12 Aug 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8406821BUG00253HB Basic UDI-DI 00195278516343UDI-DIDate19 Jan 2022RegisteredStatusActive

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 24 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  • Withdrawn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
Vivid
Generic Name
Cardiovascular ultrasound imaging system
Model / Reference
Vivid E95_Vivid E90_Vivid E80 EUDAMED
Vivid E v203 v204 to v206 UPG EUDAMED
E v203 v204 to v206 UPG GUDID
Primary DI / UDI-DI
00195278516343
Basic UDI-DI
8406821BUG00253HB
Direct Marketing DI
00195278516343
510(k) Number
FDA Product Code
ITX, OBJ, IYO, IYN
EMDN Code
Z11040102 Cardiology ultrasound scanners
GMDN Term
Cardiovascular ultrasound imaging system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1570, 870.1200, 892.1560, 892.1550
EU market of registration
Norway
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Vivid E95_Vivid E90_Vivid E80
Vivid E v203 v204 to v206 UPG
GUDID
E v203 v204 to v206 UPG
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
NO-MF-000000553

Other devices from Ge Vingmed Ultrasound

See all devices from Ge Vingmed Ultrasound →

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