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Vscan Air

by GE Vingmed Ultrasound AS Norway EUDAMEDGUDID

Ref Vscan Air R3.1 for iOS, Vscan Air R2 for iOS, Vscan Air R3.1 for Android, Vscan Air R3.2 for iOSModel Vscan Air R2 for iOS, Vscan Air R2 for Android, Vscan Air R3 for iOS, Vscan Air R3 for Android Product code IYOEMDN Z11040192

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00198953079256 UDI-DIDate26 Sep 2023ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number8406821BUG00375HS Basic UDI-DIDate8 Sep 2023RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
Vscan Air EUDAMEDGUDID
Vscan GUDID
Generic Name
Ultrasound imaging system application software
Model / Reference
Vscan Air R2 for iOS EUDAMED
Vscan Air R2 for Android EUDAMED
Vscan Air R3 for iOS EUDAMED
Vscan Air R3 for Android EUDAMED
Vscan Air R3.1 for iOS EUDAMED
Vscan Air R3.1 for Android EUDAMED
Vscan Air R3.2 for iOS EUDAMED
Air R2 for iOS GUDID
R3.2 for iOS GUDID
Air R3.1 for iOS GUDID
Air R3.1 for Android GUDID
Primary DI / UDI-DI
00198953079256, 00195278640550, 00198953079249, 00198953157152
Basic UDI-DI
8406821BUG00375HS
510(k) Number
FDA Product Code
IYO, IYN, ITX
EMDN Code
Z11040192 Ultrasound scanners - medical device software
GMDN Term
Ultrasound imaging system application software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1560, 892.1550, 892.1570
Special Device Type
Software
Market of Registration
Austria
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (8)

  • EUDAMED 07caa1fa-b518-4734-a150-a3e92b2cabb3 61 fields · synced 24 Oct 2026
  • EUDAMED 00195278640550|8406821BUG00375HS 61 fields · synced 17 May 2026
  • EUDAMED 00198953079249|8406821BUG00375HS 61 fields · synced 17 May 2026
  • FDA UDI 655b04f2-83dc-4859-9711-5147d005c236 34 fields · synced 30 May 2026
  • EUDAMED 00198953157152|8406821BUG00375HS 61 fields · synced 17 Jul 2026
  • FDA UDI 328ca3c4-90a0-4cc5-a5b1-a52df6203b18 34 fields · synced 23 Oct 2026
  • FDA UDI b66d165d-8a80-420d-a4ae-a1ffdb1d5c33 34 fields · synced 23 Oct 2026
  • FDA UDI 33a3d6cf-70d0-45a9-b09c-ac1da3294ffb 34 fields · synced 23 Oct 2026