Skip to content

SonoScape L2-9

by Sonoscape Medical Corp.

Ref _Model L2-9

SonoScape L2-9 is a device classified as Class IIa in the EU and Class II in the US made by Sonoscape Medical Corp., cleared under FDA 510(k) K241949 on 17 Jan 2025, registered in EUDAMED on 1 Sep 2023 (Basic UDI-DI 69458686P1002QL) and listed in FDA GUDID since 2 Apr 2025 (UDI-DI 06945868609092), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241949

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06945868609092 UDI-DI Date2 Apr 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK241949 Date17 Jan 2025DecidedStatusActive
European UnionCE/MDR EUDAMED Number69458686P1002QL Basic UDI-DI 06945868609092UDI-DIDate1 Sep 2023RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K241949 decided 17 Jan 2025 Active
  • EUDAMED Basic UDI-DI 69458686P1002QL registered 1 Sep 2023 Active
  • FDA GUDID UDI-DI 06945868609092 listed 2 Apr 2025 Listed

Timeline

3 dated events

  1. Registered EUDAMED 69458686P1002QL
  2. Cleared FDA 510(k) K241949
  3. Listed FDA GUDID 06945868609092

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
L2-9 EUDAMED
SonoScape GUDID
Generic name
Extracorporeal ultrasound imaging transducer, hand-held
Device name
Ultrasonic Transducer
Model / reference
L2-9, _
Primary DI / UDI-DI
06945868609092
Basic UDI-DI
69458686P1002QL
Direct marketing DI
06945868609092
510(k) Number
FDA product code
IYN, IYO, ITX
EMDN code
Z110402010101 Two–dimensional linear–array transcutaneous ultrasound probes
GMDN term
Extracorporeal ultrasound imaging transducer, hand-held
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1550, 892.1560, 892.1570
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Extracorporeal ultrasound imaging transducer, hand-held

Cleared under the same submission (K241949)

Similar devices in this category

Other devices filed under TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES.

Other devices from Sonoscape Medical Corp.

See all devices from Sonoscape Medical Corp. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)