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Trinity
EUDAMEDFDA 510(k)FDA UDIClass IIa (EU MDR)
Ref KURO-3000-3Model TRINITY510(k) K160357510(k) K170521
by Koelis
Identity
- Trade Name
- TRINITY EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- TRINITY EUDAMEDA mobile workstation composed by a central unit with ultrasound beamformer, a tactile screen, a mouse, a touch pen and a footswitch. All these components are assembled on a mobile cart. Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse. FDA UDI
- Model / Reference
- TRINITY EUDAMEDKURO-3000-3 EUDAMEDFDA UDI
- Description
- A mobile workstation composed by a central unit with ultrasound beamformer, a tactile screen, a mouse, a touch pen and a footswitch. All these components are assembled on a mobile cart. Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03665134000684 EUDAMEDFDA UDI
- Basic UDI-DI
- 3665134TRINITY_01PL EUDAMED
- 510(k) Number
- FDA Product Code
- IYN FDA 510(k)LLZ FDA UDIIYO FDA UDIITX FDA UDI
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.1550 FDA 510(k)
- Regulation Number
- 892.1550 FDA 510(k)892.2050 FDA UDI892.1560 FDA UDI892.1570 FDA UDI
- Market of Registration
- France EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Trinity by Koelis — Class IIa — MDD, FDA_510K, MDR — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 3665134TRINITY_01PL | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K170521 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K160357 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 3665134TRINITY_01PL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Koelis
- EUDAMED SRN
- FR-MF-000000830
Sources (4)
- EUDAMED 5111b81a-1c28-4367-be64-f65e28edc972 85 fields · synced Jul 18, 2026
- FDA 510(k) K170521 24 fields · synced May 18, 2026
- FDA UDI 36014d2b-6a8c-40d9-9842-e4740bc8dc59 36 fields · synced May 30, 2026
- EUDAMED da2f690f-380c-4ceb-93a6-672d339591fa 61 fields · synced Jul 18, 2026