FDA.reportPublic FDA data

Magnifier

Primary DI
06935740746595
Brand
Magnifier
Company
Urit Medical Electronic Co., Ltd.
Model
EX-06 ;1Pc/Box
Published
2025-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HJFMagnifier, Hand-Held, Low-Vision

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJFMagnifier, Hand-Held, Low-VisionOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06935740746595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06935740746595069357407465956935740746595

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held magnifierA magnifying ophthalmic lens with a handle intended to enlarge text/images for a visually impaired patient/person. It is also known as a magnifying glass and can be made of solid plastic material or glass within a plastic or metal frame.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
653742429
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06935740725705Blood Lipid AnalyzerPFS-30,1 Set/box2026-06-03
06935740725712Blood Lipid AnalyzerPFS-30A,1 Set/box2026-06-03
06935740730655Uric Acid MeterURIT-10,1 Set/box2026-06-03
06935740730679Uric Acid MeterPA-11,1 Set/box2026-06-03
06935740730716Hemoglobin MeterPH-01,1 Set/box2026-06-03
06935740730723Hemoglobin MeterPH-01A,1 Set/box2026-06-03
06935740751773Urine StripsUrineRS-11-MA2026-06-03
06935740751780URINE REAGENT STRIPSURITEST 11G2026-06-03
06935740751797URINE REAGENT STRIPSURITEST 13G2026-06-03
06935740751803Urine StripsUrineRS-132026-06-03
06935740751810Urine StripsUrineRS-102026-06-03
06935740751827URINE REAGENT STRIPSURITEST 10G2026-06-03
06935740751834Urine StripsUrineRS-112026-06-03
06935740751841Urine AnalyzerHTI CL-50 Plus2026-06-03
06935740751858Urine AnalyzerHTI CL-5002026-06-03
06935740751865URINE ANALYZERURITEST-500B2026-06-03
06935740751872URINE ANALYZERURITEST-502026-06-03
06935740751452Aspartate Aminotransferase Test StripPS 92B,25 strips/vial ×4/box2026-06-01
06935740751469Aspartate Aminotransferase Test StripPS 92A,25 strips/vial ×4/box2026-06-01
06935740751476Aspartate Aminotransferase Test StripPS 92.25 strips/vial ×4/box2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740746601MagnifierUrit Medical Electronic Co., Ltd.HJF2025-09-22
00810712013393Eagle EyesEagle EyesHJF2020-08-31
00810712013409Eagle EyesEagle EyesHJF2020-08-31