AUTO REF/KERATOMETER

Basic Information

• Brand Name: AUTO REF/KERATOMETER
• Primary DI: 06971821402073
• Version / Model: RM-9600
• Company Name: Ningbo Ming Sing Optical R & D Co., Ltd.
• Labeler DUNS: 654386890
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-19
• Public Version: 1
• Public Version Date: 2022-01-27
• Public Version Status: New
• Public Device Record Key: 20783454-d49f-463d-9c1b-1f67d22fe124

Device Description

This instrument is used to measure the spherical refractive-power, cylindrical refractive power, the direction of astigmatic axis. RM-9600 Measuring fuction include refractive measurement. RM-9600 Auto refractometer Fashionable design and perfect in details Equipped with ARM Cortex-A8 processor, facilitating fast calculations Upgraded refractive and keratometry measurement technique, providing more comprehensive image analyzing Electric chin rest lifting, automatic tracing and focusing(Y axis) provides more intellectual operation 7 inch touch screen with adjustable angle and ergonomic structure design

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
HKO	Refractometer, Ophthalmic	Ophthalmic	886.1760	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36386	Automated ophthalmic refractometer	An electrically-powered, ophthalmic device designed to be used by a healthcare professional to objectively measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) by measuring how light is changed when it enters the patient's eye(s). The device emits light into the eye and detects the light reflection which is measured for sphere, cylinder, axis and/or high order aberration measurements, typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Also known as an aberrometer, the device uses this information to automatically calculate the lens prescription needed to correct the patient's vision.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06971821402073	GS1

Customer Contacts

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