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Convex probe C3S-E

by CHISON Medical Technologies Co., Ltd.

Ref C3S-E

Convex probe C3S-E is a device classified as Class IIa in the EU and Class II in the US made by CHISON Medical Technologies Co., Ltd., registered in EUDAMED on 22 Jul 2026 (Basic UDI-DI 69451214Abdominal7Z), cleared under FDA 510(k) K162172 on 14 Sep 2016 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 06945121409728), 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) K162172

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 Number69451214Abdominal7Z Basic UDI-DI 06945121409728UDI-DIDate22 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06945121409728 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK162172 Date14 Sep 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69451214Abdominal7Z registered 22 Jul 2026 Active
  • FDA 510(k) K162172 decided 14 Sep 2016 Active
  • FDA GUDID UDI-DI 06945121409728 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K162172
  2. Listed FDA GUDID 06945121409728
  3. Registered EUDAMED 69451214Abdominal7Z

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  • Withdrawn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
Chison EUDAMED
Convex probe GUDID
Generic name
Extracorporeal ultrasound imaging transducer, hand-held
Device name
Ultrasound Probes
Model / reference
C3S-E
Primary DI / UDI-DI
06945121409728
Basic UDI-DI
69451214Abdominal7Z
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
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Poland
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 (K162172)

and 8 more cleared under K162172

Similar devices in this category

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

Other devices from CHISON Medical Technologies Co., Ltd.

See all devices from CHISON Medical Technologies Co., Ltd. →

Properties

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