SYSEYE

Basic Information

• Brand Name: SYSEYE
• Primary DI: 06973009600011
• Version / Model: RetiCam 3100
• Company Name: Chongqing Bio NewVision Medical Equipment Ltd.
• Labeler DUNS: 540754972
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-13
• Public Version: 1
• Public Version Date: 2020-02-21
• Public Version Status: New
• Public Device Record Key: f478a9ca-a230-48d3-a6a4-ad8d8cc7dc5b

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HKI	Camera, Ophthalmic, Ac-Powered	Ophthalmic	886.1120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10551	Ophthalmic fundus camera	An electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06973009600011	GS1

Premarket Submissions

Submission Number	Supplement Number
K190954	000