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Summit Doppler L150R-SD5

by CooperSurgical, Inc.

Part of a family of 16 devices: see the family page

Ref L150R-SD5Model L150R-SD4

Summit Doppler L150R-SD5 is a device classified as Class IIa in the EU and Class II in the US made by CooperSurgical, Inc., registered in EUDAMED on 28 May 2026 (Basic UDI-DI 0888937TD083ns43), cleared under FDA 510(k) K024197 on 3 Jan 2003 and listed in FDA GUDID since 20 Jul 2016 (UDI-DI 00888937001907), active as of 23 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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K024197

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0888937TD083ns43 Basic UDI-DI 00888937001907UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888937001907 UDI-DI Date20 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK024197 Date3 Jan 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0888937TD083ns43 registered 28 May 2026 Active
  • FDA 510(k) K024197 decided 3 Jan 2003 Active
  • FDA GUDID UDI-DI 00888937001907 listed 20 Jul 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1131-2018 FDA Class II initiated 6 Oct 2017 on shared 510(k) K024197

    The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K024197
  2. Listed FDA GUDID 00888937001907
  3. Recall initiated FDA recalls Z-1131-2018
  4. Registered EUDAMED 0888937TD083ns43

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  • Withdrawn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
Summit Doppler™ LifeDop® EUDAMED
Summit Doppler GUDID
Generic name
Noninvasive vascular ultrasound system
Device name
LifeDop™ (Vascular Dopplers) Noninvasive Vascular Ultrasound System, Battery-Powered
Model / reference
L150R-SD5, L150R-SD4
Primary DI / UDI-DI
00888937001907
Basic UDI-DI
0888937TD083ns43
510(k) Number
FDA product code
HEP
EMDN code
Z11040103 Portable ultrasound scanners
GMDN term
Noninvasive vascular ultrasound system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
884.2660
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: Noninvasive vascular ultrasound system

Cleared under the same submission (K024197)

and 8 more cleared under K024197

Similar devices in this category

Other devices filed under PORTABLE ULTRASOUND SCANNERS.

Other devices from CooperSurgical, Inc.

See all devices from CooperSurgical, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)