Sugentech Inc._Osong Branch

Address:721-26, Jeongjungyeonje-ro, Osong-eup, Heungdeok-gu,Cheongju-si Chungbuk,KR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Kit, Test, Pregnancy, Hcg, Over The Counter (LCX) (2) Test, Luteinizing Hormone (Lh), Over The Counter (NGE) (2)

Premarket Exempt

No Yes

Clear

Surearly™ Digital Pregnancy Test - 08809408860191 Catalog Number : HCGR001E

Device Description : Surearly™ Digital Pregnancy Test is a digital test reader with a LCD display, co Surearly™ Digital Pregnancy Test is a digital test reader with a LCD display, combining with an absorbent tip covered by a plastic cap. The absorbent tip that protrudes from the end of the test reader absorbs and delivers urine to reagents on a RAPID type test strip which is located inside a plastic housing of the device. The test reader is automatically switched on, by removing the power film located at the grip. The absorbent tip is placed in urine stream directly or alternatively immersed into the collected urine. The test reader detects the colored lines and shows the digital test result on the display.

Device Class : 2

Duns Number: 694860936

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

Surearly™ Digital Ovulation Test - 08809408860214 Catalog Number : HLHM007E

Device Description : Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for th Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for the rapid determination of Luteinizing Hormone (LH) in urine. The test is for the qualitative detection of LH to predict a woman’s most fertile period. It is intended for non-professional, over-the-counter (OTC) use only.

Device Class : 1

Duns Number: 694860936

Premarket Exempt : Yes

Product Code : NGE

Prescription Use : No

Device Count : 7

Surearly™ Digital Ovulation Test - 08809408860245 Catalog Number : HLHM020E

Device Class : 1

Duns Number: 694860936

Premarket Exempt : Yes

Product Code : NGE

Prescription Use : No

Device Count : 20

Surearly™ Pregnancy Test Strip - 08809408860597 Catalog Number :

Device Description : Surearly™ Pregnancy Test Strip is a strip coated with reagents. One end of the s Surearly™ Pregnancy Test Strip is a strip coated with reagents. One end of the strip is a sample pad for urine dipping, and the control and test regions are located in the middle of the strip. Users immerse the sample pad of the strip into the collected urine and see the test results from the colored lines appeared on the strip. The test results are interpreted by users according to the instructions for use.

Device Class :

Duns Number: 694860936

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 3

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