Skip to content

Trinity

by Koelis

Ref KURO-3000-3Model TRINITY510(k) K170521

Trinity (KURO-3000-3) is a general-purpose ultrasound imaging system (EU MDR Class IIa; FDA Class II) 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 (1 earlier submission) and listed in FDA GUDID since 31 Mar 2022 (UDI-DI 03665134000684), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170521↗

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3665134TRINITY_01PL Basic UDI-DI 03665134000684UDI-DIDate23 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03665134000684 UDI-DI Date31 Mar 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK170521 Date30 May 2017ClearedStatusActive

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· +1 more in the status table
  • FDA GUDID UDI-DI 03665134000684 listed 31 Mar 2022 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K160357
  2. Cleared FDA 510(k) K170521
  3. Listed FDA GUDID 03665134000684
  4. Registered EUDAMED 3665134TRINITY_01PL

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Generic name
General-purpose ultrasound imaging system
Model / reference
TRINITY, KURO-3000-3
Primary DI / UDI-DI
03665134000684
Basic UDI-DI
3665134TRINITY_01PL
510(k) Number
FDA product code
IYN 510(k)
LLZ GUDID
IYO GUDID
ITX GUDID
EMDN code
Z11040104 Multidisciplinary ultrasound scanners (internal and cardiology, etc.)
GMDN term
General-purpose ultrasound imaging system
Device class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 892.1550 510(k)
892.2050 GUDID
892.1560 GUDID
892.1570 GUDID
EU registration type
Standard device
EU market of registration
France
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 3 fields differ

FieldEUDAMED510(k)GUDID
FDA product codeEUDAMED
—
510(k)
IYN
GUDID
LLZ
IYO
ITX
Device classEUDAMED
Class IIa
510(k)
Class II
GUDID
Class II
Regulation numberEUDAMED
—
510(k)
892.1550
GUDID
892.2050
892.1560
892.1570

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
FR-MF-000000830

Similar devices in this category

Other devices filed under MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.).

Other devices from Koelis

See all devices from Koelis →

Properties

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