Data / Medical devices / South Korea / Haenim CO.,LTD.
Haenim CO.,LTD.: FDA-registered device maker in Seo-gu Incheon, South Korea, 1 510(k) clearance
Haenim CO.,LTD. is registered with the FDA (registration 3012119286) in Seo-gu Incheon, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 29, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012119286
- Address
- 15, Saryeom-ro 21beon-gil, Seo-gu Incheon, South Korea, 22743
- Owner or operator
- Haenim Co., Ltd. (10049844)
- Roles
- Manufacturer
- First device listed
- August 11, 2015
- Registered through
- 2026
- Brand names listed
- Powered Breast Pump (Models 7V and 7X), UV Sanitizer&Dryer [Models WA-(9800L,9900N,9900L,9940L,9950L,9955T,9960L,9965T,9970L,9975T)] HN-(03L,04L,F5,SS,M1)Series
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Disinfectant, Medical Devices | LRJ | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 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 |
|---|---|---|---|---|---|---|
| June 29, 2022 | K211016 | Powered Breast Pump (Models 7V and 7X) | HGX | Substantially Equivalent | Haenim Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 29, 2022. 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.