MAGENTIQ-COLO (ME-APDS)

Basic Information

• Brand Name: MAGENTIQ-COLO (ME-APDS)
• Primary DI: 07290020140012
• Version / Model: APDS-DA-CU
• Company Name: MAGENTIQ EYE LTD
• Labeler DUNS: 600326787
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-21
• Public Version: 1
• Public Version Date: 2025-08-29
• Public Version Status: New
• Public Device Record Key: a1549dc8-e81d-4dca-b908-574b939db8f0

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QNP	Gastrointesinal Lesion Software Detection System	Gastroenterology, Urology	876.1520	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64688	Endoscopic video image interpretive unit	An electrically-powered computing unit intended to analyse endoscopic video images to automatically detect and localize suspected abnormalities and lesions (e.g., polyps) in real-time. It interfaces with an endoscopic video image processing unit and display monitor, and will typically use artificial intelligence (AI)/deep learning software to identify abnormalities and overlay visual flags/markers on video images to highlight regions of interest to clinicians.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290020140012	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]