AUTO REF/KERATOMETER

Basic Information

• Brand Name: AUTO REF/KERATOMETER
• Primary DI: 06971821402011
• Version / Model: RM-9000
• 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: 2019-12-02
• Public Version: 3
• Public Version Date: 2020-12-21
• Public Version Status: Update
• Public Device Record Key: 618c4c33-b392-40ad-9918-635eae800d14

Device Description

This instrument is used to measure the spherical refractive-power, cylindrical refractive power, the direction of astigmatic axis. RM-9000 Measuring fuction only has refractive measurement. RM-9000 Auto refractometer Adopts the ARM processor and image processing technology in China—faster system and clearer image Mature technique from Japan. Humanized auto mist test process: will reduce errors caused by human eye adjustments—more accurate measure results Integral pressing and CNC machining for the optical rack: ensure the measurement consistency and accuracy—more stable system 5.7" LCD color screen provides more comfortable interface Supports the data transmission with auto phoropter, improving the work efficiency Auto PD measurement One-key lock function, enables to lock the moving head faster Novel design and ergonomic structure can give the customer a sense of beauty and comfortable operation.

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	06971821402011	GS1

Customer Contacts

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