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Venue Fit R4 UPG

by GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Ref Venue Fit R4 UPGModel Venue Fit

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00195278513014 UDI-DI Date30 Jun 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8406821BUG00285HQ Basic UDI-DI 00195278513014UDI-DIDate17 Feb 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

1 recall · 1 ongoing · FDA

    • Ongoing Z-1556-2025 FDA Class II initiated 6 Mar 2025

    The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

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  • Withdrawn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
Venue Fit R4 UPG EUDAMED
Venue Fit GUDID
Generic Name
General-purpose ultrasound imaging system
Model / Reference
Venue Fit EUDAMED
Venue Fit R4 UPG EUDAMED
R4 UPG GUDID
Primary DI / UDI-DI
00195278513014
Basic UDI-DI
8406821BUG00285HQ
Direct Marketing DI
00195278513014
510(k) Number
FDA Product Code
ITX, IYN, IYO
EMDN Code
Z11040101 Internal ultrasound scanners
GMDN Term
General-purpose ultrasound imaging system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1570, 892.1550, 892.1560
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Venue Fit
Venue Fit R4 UPG
GUDID
R4 UPG
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000016119
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Other devices from GE Medical Systems Ultrasound and Primary Care Diagnostics LLC

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Properties

  • Measuring Function
  • Prescription Use
  • Lot / Batch 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No