FDA.reportPublic FDA data

OptochekPlus

Primary DI
00812559012249
Brand
OptochekPlus
Company
REICHERT, INC.
Model
15170
Published
2025-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HKLRetinoscope, Ac-Powered
HKORefractometer, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKLRetinoscope, Ac-PoweredOphthalmic2
HKORefractometer, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812559012249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812559012249008125590122498125590122490812559012249

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
126650253
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812559010580PDM Digital PD Meter150202025-08-12
00812559010115Ocu-Film +2306512016-09-22
00812559012096Ocu-Film +2306532016-09-22
00812559012485" Ocu-Film® +"""2306532025-08-15
00812559012492"Ocu-Film® +"""2306512025-08-14
00812559011136UNISTAT® Bilirubinometer Specimen Cuvettes131021402025-08-12
00812559012454Ocu-Dot® Tonometer Probes - 100 Count163182025-08-12
00812559010238Ultramatic RX Master Phoropter11625B2025-08-12
00812559010269Ultramatic RX Master Phoropter11635B2025-08-12
00812559010290Illuminated Phoropter116362025-08-12
00812559010320Illuminated Phoropter116372025-08-12
00812559010559TF50 Trial Frame150102025-08-12
00812559010566TS75 Trial Lens150152025-08-12
00812559010900Tono-Vera® Tonometer Starter Kit, Rechargeable163062025-08-12
00812559011143UNISTAT® Bilirubinometer Specimen Cuvettes131021402025-08-12
00812559011419Quebec® Manual Darkfield Colony Counter133325002025-08-12
00812559011440Quebec® Digital Darkfield Colony Counter133327002025-08-12
00812559011495Reichert® Digital USG-Chek139400192025-08-12
00812559011518Clinical Refractometers Reichert® Digital Clinic-Chek139400212025-08-12
00812559011716Phoropter VRx162412025-08-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095540342zumaxZumax Medical Co., LTDHKL2026-05-20
06945095543923zumaxZumax Medical Co., LTDHKL2026-05-20
06945095544333zumaxZumax Medical Co., LTDHKL2026-05-20
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
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