FDA.reportPublic FDA data

MOPTIM

Primary DI
06972039971542
Brand
MOPTIM
Company
Shenzhen CERTAINN Technology Co., Ltd.
Model
iRef
Device description
The manual refractometer is composed of a lens and a removable eye chart. The testee is required to move the position of the eye chart after resetting to make the visual target become clearer from blur. Once the clearest position of the visual target is determined, the testee’s estimated refractive error can be read from the display screen of the instrument.
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
06972039971542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972039971542069720399715426972039971542

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held subjective ophthalmic refractometerA hand-held ophthalmic device intended to be used by a layperson to measure the refractive error of their eye (the inaccuracies of focusing light upon the retina), typically to test their vision. It is typically in the form of a monocular which contains lenses of different characteristics; a dedicated software providing examination protocols may also be included. The patient changes the lenses and other settings while reading an eye chart to subjectively evaluate which settings give best vision.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure86 KiloPascal106 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure86 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Regulatory Flags#

DUNS number
526992561
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

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
06972039971641MOPTIMDEA2022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971922136334YEASNChongqing Yeasn Science & Technology Co.,Ltd.HKO2026-04-25
03615020000014AKR 550ESSILOR INTERNATIONALHKO2026-02-23
03615020000441AKR 800ESSILOR INTERNATIONALHKO2026-02-23
08800019600954Vision ScreenerHuvitz Co., Ltd.HKO2026-02-13
B43050085700GoCheck KidsGobiquity, Inc.HKO2026-01-09
04987669204610Open-field Refraction SystemNIDEK CO.,LTD.HKO2026-01-08
04987669204917Open-field Refraction SystemNIDEK CO.,LTD.HKO2026-01-08
04560126269188AUTO KERATO-REFRACTOMETER KR-1TOPCON CORPORATIONHKO2025-11-21
B43071000030GoCheck MultiScreenerGobiquity, Inc.HKO2025-11-19
B43050085610GoCheck KidsGobiquity, Inc.HKO2025-11-04
04560126269140AUTO KERATO-REFRACTOMETER KR-800TOPCON CORPORATIONHKO2025-10-31
04560126269164AUTO REFRACTOMETER RM-800TOPCON CORPORATIONHKO2025-10-31
B43050085600GoCheck KidsGobiquity, Inc.HKO2025-10-22
00860014277528S4Optik REF-K2000Lombart Brothers, Inc.HKO2025-10-18
04540008310030RexxamREXXAM CO., LTD.HKO2025-10-17
04540008310320RexxamREXXAM CO., LTD.HKO2025-10-17
04540008310436RexxamREXXAM CO., LTD.HKO2025-10-17
04540008310443RexxamREXXAM CO., LTD.HKO2025-10-17
04540008310603RexxamREXXAM CO., LTD.HKO2025-10-17
06973211071869Kerato refractometerCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDHKO2025-08-18
06973211071876Kerato refractometerCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDHKO2025-08-18
00812559012249OptochekPlusREICHERT, INC.HKO2025-08-12
04571130283381AUTO KERATO-REFRACTOMETER KR-1TOPCON CORPORATIONHKO2025-06-19
04571130283404AUTO KERATO-REFRACTOMETER KR-800PATOPCON CORPORATIONHKO2025-05-12
04560126268662SightPilot NAVi Controller SNi-1 COMPU VISION CV-5000 REFRACTION SYSTEM ChronosTOPCON CORPORATIONHKO2025-05-01
04571130283367AUTO KERATO-REFRACTOMETER KR-800ATOPCON CORPORATIONHKO2025-04-15
B43050085500GoCheck KidsGobiquity, Inc.HKO2025-03-20
03664188000169VISIONIXLUNEAU TECHNOLOGY OPERATIONSHKO2025-01-02
03664188000558ESSILORLUNEAU TECHNOLOGY OPERATIONSHKO2025-01-02
03664188000565ESSILORLUNEAU TECHNOLOGY OPERATIONSHKO2025-01-02