MOPTIM

Basic Information

• Brand Name: MOPTIM
• Primary DI: 06972039971016
• Version / Model: R2X
• Company Name: Shenzhen CERTAINN Technology Co., Ltd.
• Labeler DUNS: 526992561
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-23
• Public Version: 1
• Public Version Date: 2025-07-01
• Public Version Status: New
• Public Device Record Key: f9673d4e-ac5f-4dfe-b4d1-04e78c39d0b8

Device Description

The Handheld Auto Refractometer uses the infrared fundus reflection phase method to emit a beam of infrared light with a specific wavelength, through the subject's cornea, lens, etc., and finally projected to the eye retina, and then reflected back to the corresponding optical system of the instrument. The image is taken through the image sensor, and the spherical refraction power, cylindrical refraction power and astigmatism axis are calculated after image processing and signal processing, which is used to determine the refractive state of human eyes.

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HKN	Refractor, Manual, Non-Powered, Including Phoropter	Ophthalmic	886.1770	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	06972039971016	GS1