MOPTIM

GUDID 06972039971016

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.

Shenzhen CERTAINN Technology Co., Ltd.

Automated ophthalmic refractometer

• Primary Device ID: 06972039971016
• NIH Device Record Key: f9673d4e-ac5f-4dfe-b4d1-04e78c39d0b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOPTIM
• Version Model Number: R2X
• Company DUNS: 526992561
• Company Name: Shenzhen CERTAINN Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972039971016 [Primary]

FDA Product Code

• HKN: Refractor, Manual, Non-Powered, Including Phoropter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-01
• Device Publish Date: 2025-06-23

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