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2D Abdominal Probe K2DAB00

by Koelis

Ref K2DAB00Model TRINITY

2D Abdominal Probe K2DAB00 is a device classified as Class IIa in the EU and Class II in the US made by Koelis, registered in EUDAMED on 23 Apr 2026 (Basic UDI-DI 3665134TRINITY_01PL), cleared under FDA 510(k) K170521 on 30 May 2017 and listed in FDA GUDID since 5 Apr 2023 (UDI-DI 03665134000097), 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) K170521

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 Number3665134TRINITY_01PL Basic UDI-DI 03665134000097UDI-DIDate23 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03665134000097 UDI-DI Date5 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK170521 Date30 May 2017IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3665134TRINITY_01PL registered 23 Apr 2026 Active
  • FDA 510(k) K170521 decided 30 May 2017 Active
  • FDA GUDID UDI-DI 03665134000097 listed 5 Apr 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K170521
  2. Listed FDA GUDID 03665134000097
  3. Registered EUDAMED 3665134TRINITY_01PL

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  • Withdrawn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
2D Abdominal Probe
Generic name
General-purpose ultrasound imaging system
Device name
Trinity
Model / reference
K2DAB00, TRINITY
Primary DI / UDI-DI
03665134000097
Basic UDI-DI
3665134TRINITY_01PL
510(k) Number
FDA product code
ITX
EMDN code
Z110402010201 Curvilinear transcutaneous two–dimensional ultrasound probes (convex–array)
GMDN term
General-purpose ultrasound imaging system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1570
EU registration type
Standard device
EU market of registration
France
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: General-purpose ultrasound imaging system

Cleared under the same submission (K170521)

and 1 more cleared under K170521

Similar devices in this category

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

Other devices from Koelis

See all devices from Koelis →

Properties

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