Data / Medical devices / South Korea / HLB Life Science Co., Ltd.
HLB Life Science Co., Ltd.: FDA-registered device maker in Anseong-si, Gyeonggi-do, South Korea, 3 510(k) clearances
HLB Life Science Co., Ltd. is registered with the FDA (registration 3030089798) in Anseong-si, Gyeonggi-do, South Korea. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 21, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3030089798
- Address
- 122-39, Gieopdanji-ro, Gongdo-eup, Anseong-si, Gyeonggi-do, South Korea, 17551
- Owner or operator
- HLB Life Science Co., Ltd. (10089317)
- Roles
- Manufacturer
- First device listed
- June 25, 2024
- Registered through
- 2026
- Brand names listed
- Irrigation Syringe, Catheter Tip Syringe/Sofjec, CarePoint Precision, Membrane Filter Syringe/Sofjec, CarePoint Precision, Single use Membrane Filter Syringe/Sofjec, CarePoint Precision, Single use Needle/Sofjec, CarePoint Precision, Single use Syringe with Needle/Sofjec, CarePoint Precision, Single use Syringe with or without Needle/Sofjec, CarePoint Precision, Single use Syringe with/without Needle/Sofjec, CarePoint Precision
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Low Dead Space Piston Syringe | QNQ | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| May 21, 2026 | K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | FMF | Substantially Equivalent | Hlb Lifescience Co., Ltd. | accessdata.fda.gov |
| December 23, 2024 | K241856 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | FMF | Substantially Equivalent | Hlb Lifescience Co., Ltd. | accessdata.fda.gov |
| February 13, 2023 | K212635 | Sofjec | FMF | Substantially Equivalent | Hwajin Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Irrigating (Non Dental)
- All makers of Low Dead Space Piston Syringe
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
- All makers of Syringe, Antistick
Updated May 21, 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.