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CH5-2 Transducer 10136141

by Siemens Medical Solutions USA, Inc.

Ref 10136141Model MDR_07_IIA_IQH_BTS LB A_ACDV_CH5-2_10136141

CH5-2 Transducer 10136141 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 0405686902402V9), cleared under FDA 510(k) K233610 on 12 Jun 2024 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04056869027241), 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) K233610

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0405686902402V9 Basic UDI-DI 04056869027241UDI-DIDate8 Sep 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK233610 Date12 Jun 2024DecidedStatusActive
United StatesGUDID listing GUDID Number04056869027241 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0405686902402V9 registered 8 Sep 2026 Active
  • FDA 510(k) K233610 decided 12 Jun 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04056869027241 listed 24 Sep 2016 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K121699
  2. Listed FDA GUDID 04056869027241
  3. Cleared FDA 510(k) K233610
  4. Registered EUDAMED 0405686902402V9

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  • Withdrawn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
CH5-2 Transducer
Generic name
Extracorporeal ultrasound imaging transducer, hand-held
Device name
MDR_07_IIA_IQH_BTS Lb A_ACDV_CH5-2_10136141
Model / reference
10136141, MDR_07_IIA_IQH_BTS LB A_ACDV_CH5-2_10136141
Primary DI / UDI-DI
04056869027241
Basic UDI-DI
0405686902402V9
510(k) Number
FDA product code
ITX
EMDN code
Z110402010201 Curvilinear transcutaneous two–dimensional ultrasound probes (convex–array)
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

Category: Extracorporeal ultrasound imaging transducer, hand-held

Cleared under the same submission (K121699)

and 8 more cleared under K121699

Cleared under the same submission (K233610)

and 7 more cleared under K233610

Similar devices in this category

Other devices filed under CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY).

Other devices from Siemens Medical Solutions USA, Inc.

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

Properties

  • Serial number
Other properties (24, all answered No)