Data / Medical devices / South Korea / Sugentech, Inc.
Sugentech, Inc.: FDA-registered device maker in Cheongju-si Chungbuk, South Korea, 1 510(k) clearance
Sugentech, Inc. is registered with the FDA (registration 3010879605) in Cheongju-si Chungbuk, South Korea. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 7, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010879605
- Address
- 721-26, Jeongjungyeonje-ro, Osong-eup, Heungdeok-gu, Cheongju-si Chungbuk, South Korea, 28161
- Owner or operator
- Sugentech, Inc. (10046776)
- Roles
- Foreign private label distributor, Manufacturer
- First device listed
- May 11, 2014
- Registered through
- 2026
- Brand names listed
- Surearly Digital Ovulation Test, Surearly Digital Pregnancy Test, Surearly Ovulation Test Strip, Surearly Pregnancy Test Strip, Surearly SMART, Surearly SMART Menopause Test, Surearly SMART Ovulation Test, Surearly SMART Ovulation Test Starter Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Manufacturer | accessdata.fda.gov |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | 1 | Manufacturer | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Collection, Capillary Blood | GIO | 1 | Foreign private label distributor | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 7, 2016 | K142754 | Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test | LCX | Substantially Equivalent | Sugentech, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Tube, Collection, Capillary Blood
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Test, Follicle Stimulating Hormone (Fsh), Over The Counter
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
Updated April 7, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.