Data / Medical devices / Ireland / Cosmo Artificial Intelligence, Ltd
Cosmo Artificial Intelligence, Ltd: FDA-registered device maker in Dublin 2 Dublin(County), Ireland, 3 510(k) clearances
Cosmo Artificial Intelligence, Ltd is registered with the FDA (registration 3018899987) in Dublin 2 Dublin(County), Ireland. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated May 29, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018899987
- Address
- Riverside II, Sir John Rogerson's Quay, Dublin 2 Dublin(County), Ireland, D02KV60
- Owner or operator
- Cosmo Artificial Intelligence, Ltd (10081320)
- Roles
- Exporter to the US
- First device listed
- February 16, 2024
- Registered through
- 2026
- Brand names listed
- ColonPRO 4, ColonPRO 4 (CPRO40.US), ColonPRO 4 (CPRO401-US), ColonPRO 4 (CPRO40S-US), ColonPRO US, Footswitch, GI Genius Module 100, GI Genius Module 200 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Gastrointesinal Lesion Software Detection System | QNP | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 29, 2026 | K261369 | GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US) | QNP | Substantially Equivalent | Cosmo Artificial Intelligence - Ai, Ltd. | accessdata.fda.gov |
| July 25, 2024 | K241887 | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US) | QNP | Substantially Equivalent | Cosmo Artificial Intelligence - Ai, Ltd. | accessdata.fda.gov |
| January 12, 2024 | K233964 | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US) | QNP | Substantially Equivalent | Cosmo Artificial Intelligence - Ai, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.