FDA.reportPublic FDA data

Surearly SMART

Primary DI
08809408864113
Brand
Surearly SMART
Company
Sugentech Inc._Osong Branch
Model
Surearly SMART
Catalog number
SSFD001E
Device description
Surearly SMART is a self-testing in vitro diagnostic device for home-use that displayed qualitative or semi-quantitative results from a test stick that detects various hormones such as hCG, LH, FSH, etc in human urine. The firmware-driven Surearly SMART measures the color degree of the test stick using optical methods according to the visible light reflectance. The measured data is transmitted to the App via Bluetooth, and the analyzed results are transmitted back to the Surearly SMART and displayed.
Published
2026-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter
NGETest, Luteinizing Hormone (Lh), Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGATest, Follicle Stimulating Hormone (Fsh), Over The CounterClinical Chemistry1
NGETest, Luteinizing Hormone (Lh), Over The CounterClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809408863499PreviousGS10
08809408864113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809408863499088094088634998809408863499
08809408864113088094088641138809408864113

GMDN Terms#

Term, Definition table
TermDefinition
Photometric/spectroscopic immunoassay analyser IVDAn electrically-powered instrument intended to be used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card), after vehicle exposure to a clinical specimen, to provide a quantitative, semi-quantitative and/or qualitative in vitro determination of chemical substances and/or biological markers in the clinical specimen. The instrument uses photometry and/or light spectroscopy to detect visual markers that result from the immunological reaction between the reagents and the specimen. It is intended to be used by healthcare professionals for rapid in vitro diagnostic measurements [e.g., lateral flow immunochromatographic (ICT) test] at the point-of-care or in the laboratory.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00Keep away from direct sunlight, moisture and heat

Regulatory Flags#

DUNS number
694860936
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809408864199Surearly SMART Ovulation TestSurearly SMART Ovulation TestSLHN020E2026-05-08
08809408864304Surearly SMART Ovulation Test Starter KitSurearly SMART Ovulation Test Starter KitLHKT001E2026-05-08
08809408860214Surearly™ Digital Ovulation TestSU-DR01-LHHLHM007E2020-10-26
08809408860245Surearly™ Digital Ovulation TestSU-DR01-LHHLHM020E2020-10-26
08809408863499Surearly SMARTSurearly SMART (SSMD001E)2025-05-15
08809408863505PettyPipPettyPipCT10300E2025-05-15
08809408860191Surearly™ Digital Pregnancy TestSU-DR02-CGHCGR001E2018-11-26
08809408860597Surearly™ Pregnancy Test StripHCGS003E2018-11-26
08809408863475Surearly SMART Menopause TestSurearly SMART Menopause Test2025-05-15
08809408863482Surearly SMART Ovulation TestSurearly SMART Ovulation Test2025-05-15
08809408860870Surearly™ Digital Ovulation TestSU-DR01-LHHLHM007E2020-10-26
08809408860863Surearly™ Digital Ovulation TestSU-DR01-LHHLHM020E2020-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936983120081One Step FSH Rapid Test Midstream (Urine)Hangzhou AllTest Biotech Co., Ltd.NGA2026-09-22
06974464591678One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-07-22
06974464591685One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-07-22
06923304611175FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
06923304611182FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
06923304611199FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
06923304611236FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
06923304611274FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
06923304611281FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
06974464591654One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-07-15
06972412611690LittleBeginHangzhou Laihe Biotech Co.,Ltd.NGE2026-07-13
06972412611706LittleBeginHangzhou Laihe Biotech Co.,Ltd.NGE2026-07-13
06972412611713LittleBeginHangzhou Laihe Biotech Co.,Ltd.NGE2026-07-13
00850081966005PregmateGuangzhou Decheng Biotechnology Co., LTDNGA2026-07-08
00810174470369HORMONElife™WONDFO USA CO., LTD.NGA2026-06-26
06972164410015Semi-Quantitative Follicle-Stimulating Hormone (FSH) Test StripKunming Lianen Biotechnology Co., LTDNGA2026-06-26
06938444982818DAVIDEquinox Biotech Co., Ltd.NGE2026-06-01
08809408864199Surearly SMART Ovulation TestSugentech Inc._Osong BranchNGE2026-05-08
08809408864304Surearly SMART Ovulation Test Starter KitSugentech Inc._Osong BranchNGE2026-05-08
00633472602559ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHNGE2026-05-06
00633472602566ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHNGE2026-05-06
00633472602573ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHNGE2026-05-06
06974464591296One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-03-31
06974464591302One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-03-31
06974464591319One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-03-31
00381519194696ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHNGE2026-03-23
06952062712657Luteinizing Hormone (LH) Ovulation testANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDNGE2026-03-20
06952062712664Follicle-Stimulating Hormone (FSH) Menopause testANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDNGA2026-03-20
06952062712671Luteinizing Hormone (LH) Ovulation testANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDNGE2026-03-20
06952062712688Follicle-Stimulating Hormone (FSH) Menopause testANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDNGA2026-03-20