Data / Medical devices / System, Test, Blood Glucose, Over The Counter / South Korea
FDA-registered makers of System, Test, Blood Glucose, Over The Counter in South Korea: 8 establishments
8 establishments in South Korea are registered with the FDA to make System, Test, Blood Glucose, Over The Counter (product code NBW). 8 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- System, Test, Blood Glucose, Over The Counter
- Product code
- NBW
- Country
- South Korea
Makers of System, Test, Blood Glucose, Over The Counter in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| I-Sens, Inc. | Seoul, South Korea | Specification developer | 14 | August 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| i-SENS Wonju Factory | Wonju-si Gangwon, South Korea | Contract manufacturer, Manufacturer | 14 | August 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| I-SENS Songdo Factory 2 | lncheon Incheon, South Korea | Manufacturer | 13 | August 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| i-SENS Songdo Factory | Incheon, South Korea | Contract manufacturer, Manufacturer | 10 | August 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| OSANG Healthcare CO., LTD. | ANYANG Gyeonggi, South Korea | Contract manufacturer, Manufacturer | 5 | July 13, 2021 | 0 | 0 | 0 | api.fda.gov |
| All Medicus Co., Ltd. | Anyang-si Gyeonggi, South Korea | Manufacturer | 2 | October 13, 2017 | 0 | 0 | 0 | api.fda.gov |
| SD Biosensor, Inc. | Suwon-si Gyeonggi, South Korea | Specification developer | 2 | October 17, 2017 | 0 | 0 | 0 | api.fda.gov |
| SD Biosensor, Inc. | Cheongju-si Chungbuk, South Korea | Manufacturer | 2 | October 17, 2017 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. 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.