MOPTIM

Primary DI
06972039971092
Brand
MOPTIM
Company
Shenzhen CERTAINN Technology Co., Ltd.
Model
ARK-A1
Device description
The ARK-A1 utilizes the infrared light retinal reflection phase method. It emits a specific wavelength of infrared light that passes through the cornea, lens, and other parts of the eye, ulti-mately projecting onto the retina. The light is then reflected back into the instrument's optical system. The image is captured by an image sensor and, after image processing and signal pro-cessing, the spherical lens power, cylindrical lens power, and cylindrical axis are calculated. This instrument is used to measure the refractive status of the human eye.
Published
2026-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HKORefractometer, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKORefractometer, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972039971092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972039971092069720399710926972039971092

GMDN Terms#

Term, Definition table
TermDefinition
Automated ophthalmic refractometerAn 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.

Regulatory Flags#

DUNS number
526992561
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972039971054MOPTIMC12025-08-15
06972039971085MOPTIMeasyCam2025-06-30
06972039971016MOPTIMR2X2025-06-23
06972039971023MOPTIMR3X2025-06-23
06972039971061MOPTIMOPM500D2025-06-23
06972039971078MOPTIMOPM500C2025-06-23
06972039971221MOPTIMOPM5002025-06-23
06972039971214MOPTIMeasyRef Pro2025-06-19
06972039971573MOPTIMeasyRef2023-02-03
06972039971405MOPTIMSL-M62022-12-08
06972039971542MOPTIMiRef2022-12-08
06972039971641MOPTIMDEA2022-12-08

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Primary DI, Brand, Company table
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04560126269188AUTO KERATO-REFRACTOMETER KR-1TOPCON CORPORATIONHKO2025-11-21
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