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EC9-4 Transducer 10136144

by Siemens Medical Solutions USA, Inc.

Ref 10136144Model MDR_07_IIA_IQH_BTS LB A_ACDV_EC9-4_10136144

EC9-4 Transducer 10136144 is a device classified as Class IIa in the EU and Class II in the US made by Siemens Medical Solutions USA, Inc., registered in EUDAMED on 8 Sep 2026 (Basic UDI-DI 0405686902404VD), cleared under FDA 510(k) K233610 on 12 Jun 2024 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04056869005539), 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 found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K233610

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0405686902404VD Basic UDI-DI 04056869005539UDI-DIDate8 Sep 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK233610 Date12 Jun 2024DecidedStatusActive
United StatesGUDID listing GUDID Number04056869005539 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0405686902404VD registered 8 Sep 2026 Active
  • FDA 510(k) K233610 decided 12 Jun 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04056869005539 listed 24 Sep 2016 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K150050
  2. Listed FDA GUDID 04056869005539
  3. Cleared FDA 510(k) K233610
  4. Registered EUDAMED 0405686902404VD

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  • Withdrawn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
EC9-4 Transducer
Generic name
Rectal/vaginal ultrasound imaging transducer
Device name
MDR_07_IIA_IQH_BTS Lb A_ACDV_EC9-4_10136144
Model / reference
10136144, MDR_07_IIA_IQH_BTS LB A_ACDV_EC9-4_10136144
Primary DI / UDI-DI
04056869005539
Basic UDI-DI
0405686902404VD
510(k) Number
FDA product code
ITX
EMDN code
Z1104020201 Endocavitary ultrasound probes, two–dimensional
GMDN term
Rectal/vaginal ultrasound imaging transducer
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

Category: Rectal/vaginal ultrasound imaging transducer

Cleared under the same submission (K150050)

and 6 more cleared under K150050

Cleared under the same submission (K233610)

and 7 more cleared under K233610

Similar devices in this category

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

Other devices from Siemens Medical Solutions USA, Inc.

See all devices from Siemens Medical Solutions USA, Inc. →

Properties

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