Data / Medical devices / South Korea / HLB Co., Ltd. Healthcare
HLB Co., Ltd. Healthcare: FDA-registered device maker in Yeondong-myeon Sejong, South Korea, 1 510(k) clearance
HLB Co., Ltd. Healthcare is registered with the FDA (registration 3024273968) in Yeondong-myeon Sejong, South Korea. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 13, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024273968
- Address
- 10-5 Myeonghaksandanseo-ro, Yeondong-myeon Sejong, South Korea, 30068
- Owner or operator
- HLB Co., LTD. Healthcare (10087138)
- Roles
- Manufacturer
- First device listed
- January 16, 2023
- Registered through
- 2026
- Brand names listed
- Alcohol Swab(Isopropyl Alcohol), CareSens Alcohol Prep Pads, Collection Swab, Cotton Swab, Eol Swab (Ethanol), FA Alcohol Swab S, Gum & Tooth care wipes, Nasal Swab and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Manufacturer | accessdata.fda.gov |
| Dental Hygiene Kit | NXZ | 1 | Manufacturer | accessdata.fda.gov |
| Pad, Alcohol, Device Disinfectant | LKB | U | Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 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 |
|---|---|---|---|---|---|---|
| January 13, 2025 | K243533 | Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus | FMK | Substantially Equivalent | Hlb Co., Ltd. Healthcare | accessdata.fda.gov |
Compare with other makers
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- All makers of Applicator, Absorbent Tipped, Sterile
- All makers of Dental Hygiene Kit
- All makers of Pad, Alcohol, Device Disinfectant
Updated January 13, 2025. 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.