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ultrasonic transducer E611-2

by Edan Instruments, Inc.

Part of a family of 47 devices: see the family page

Ref E611-2

ultrasonic transducer E611-2 is a device classified as Class IIa in the EU and Class II in the US made by Edan Instruments, Inc., registered in EUDAMED on 29 Jan 2026 (Basic UDI-DI 69444138UTGG), cleared under FDA 510(k) K131830 on 17 Sep 2013 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 06944413806481), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K131830

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69444138UTGG Basic UDI-DI 06944413806481UDI-DIDate29 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06944413806481 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK131830 Date17 Sep 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69444138UTGG registered 29 Jan 2026 Active
  • FDA 510(k) K131830 decided 17 Sep 2013 Active
  • FDA GUDID UDI-DI 06944413806481 listed 1 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K131830
  2. Listed FDA GUDID 06944413806481
  3. Registered EUDAMED 69444138UTGG

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  • Withdrawn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
ultrasonic transducer
Generic name
Extracorporeal ultrasound imaging transducer, hand-held
Model / reference
E611-2
Primary DI / UDI-DI
06944413806481
Basic UDI-DI
69444138UTGG
510(k) Number
FDA product code
ITX
EMDN code
Z1104020201 Endocavitary ultrasound probes, two–dimensional
GMDN term
Extracorporeal ultrasound imaging transducer, hand-held
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1570
EU registration type
Standard device
EU market of registration
Germany
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

Cleared under the same submission (K131830)

and 5 more cleared under K131830

Similar devices in this category

Other devices filed under ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL.

Other devices from Edan Instruments, Inc.

See all devices from Edan Instruments, Inc. →

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)