Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018899987

FEI Number

3018899987

Entity Name

COSMO ARTIFICIAL INTELLIGENCE, LTD

City/State/Country

Dublin 2, IE

Establishment Address

Riverside II, Sir John Rogerson's Quay, Dublin 2 D02KV60, IE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Cosmo Artificial Intelligence, Ltd (Owner Number: 10081320)

Owner / Operator Contact Address

Riverside II, Sir John Rogerson's Quay, Dublin 2, IE-D D02 KV60, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241887

PMA Number

N/A

All Registered Proprietary Names

ColonPRO 4 GI Genius Module 100 GI Genius Module 200 USB K-switch Footswitch ColonPRO 4 (CPRO401-US) ColonPRO 4 (CPRO40.US) GI Genius Module 300 GI Genius Module 200 GI Genius Module 100 ColonPRO 4 (CPRO40S-US)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QNP	Gastrointesinal Lesion Software Detection System	Gastroenterology, Urology	Class 2	876.1520	2024-02-16
QNP	Gastrointesinal Lesion Software Detection System	Gastroenterology, Urology	Class 2	876.1520	2024-09-12

Official Correspondent

No official correspondent registered.

US Agent Details

Steven Kradjian Business: Conventus Biomedical Solutions, Inc. Email: skradjian@conventusbiomed.com Phone: (858) 4012111

Related Public Records

Same Entity

Cosmo Artificial Intelligence, Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018899987. Last updated year: 2026. Please use registration number 3018899987 when referencing this establishment in official correspondence.