AccessGUDID - DEVICE: MOPTIM (06972039971016)

GUDID

Device Identifier (DI) Information

Brand Name: MOPTIM
Version or Model: R2X
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen CERTAINN Technology Co., Ltd.

Primary DI Number: 06972039971016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 526992561 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HKN	Refractor, Manual, Non-Powered, Including Phoropter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f9673d4e-ac5f-4dfe-b4d1-04e78c39d0b8
Public Version Date: July 01, 2025
Public Version Number: 1
DI Record Publish Date: June 23, 2025