FDA Registration Active 🇮🇪 Ireland

COSMO ARTIFICIAL INTELLIGENCE, LTD

Reg #: 3018899987 · FEI: 3018899987 · Expires 2026
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1

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Registration Details

Registration Name
COSMO ARTIFICIAL INTELLIGENCE, LTD
Registration Number
3018899987
FEI Number
3018899987
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Riverside II, Sir John Rogerson's Quay
City
Dublin 2
Country
IE

Regulatory Submissions

510(k) Number
K233964

Owner / Operator

Firm Name
Cosmo Artificial Intelligence, Ltd
Operator Number
10081320
Address
Riverside II, Sir John Rogerson's Quay
City
Dublin 2
State
IE-D
Postal Code
D02 KV60
Country
IE

US Agent

Business Name
Conventus Biomedical Solutions, Inc.
Contact Name
Steven Kradjian
Address
9920 Pacific Heights Blvd Ste 150
City
San Diego
State
CA
ZIP
92121
Country
US
Phone
858 4012111

Products

Device Name Product Code
Gastrointesinal Lesion Software Detection System QNP

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 ColonPRO™ 4 (CPRO40S-US)

Establishment Types

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