# Trinity

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/trinity-kuro-3000-3>
- Manufacturer: [Koelis](https://devicerts.com/manufacturers/koelis) (France)
- Name in the registry: TRINITY
- Device class: Class IIa (EU MDR); Class II (US FDA)
- FDA product code: IYN, LLZ, IYO, ITX
- EMDN: Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)
- GMDN: General-purpose ultrasound imaging system (40761)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 3665134TRINITY\_01PL · UDI-DI 03665134000684 · registered 2026-04-23 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 03665134000684 · listed 2022-03-31 · status: Listed (GUDID: in commercial distribution)
- **510(k)** · FDA 510(k) · United States · K170521 · decision 2017-05-30 · decision SESE · status: Active
- **510(k)** · FDA 510(k) · United States · K160357 · issued 2016-05-02 · status: Active

## Recalls

No recall on record.

## Identity

- Generic name: General-purpose ultrasound imaging system [FDA GUDID (AccessGUDID)]
- Model / reference: TRINITY [EUDAMED]; KURO-3000-3 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 03665134000684 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 3665134TRINITY\_01PL [EUDAMED]
- 510(k) Number: K170521 [FDA 510(k), FDA GUDID (AccessGUDID)]
- FDA product code: IYN [FDA 510(k)]; LLZ [FDA GUDID (AccessGUDID)]; IYO [FDA GUDID (AccessGUDID)]; ITX [FDA GUDID (AccessGUDID)]
- EMDN code: Z11040104 [EUDAMED]
- GMDN term: General-purpose ultrasound imaging system (40761) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA 510(k), FDA GUDID (AccessGUDID)]
- Regulation: 21 CFR Part 892.1550 [FDA 510(k)]; 892.2050 [FDA GUDID (AccessGUDID)]; 892.1560 [FDA GUDID (AccessGUDID)]; 892.1570 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: France [EUDAMED]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Measuring function: Yes [EUDAMED]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Trinity, Koelis. deviCERTS medical device catalogue. https://devicerts.com/devices/trinity-kuro-3000-3 (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-24
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/trinity-kuro-3000-3.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/trinity-kuro-3000-3
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.