Data / Medical devices / South Korea / Boldy Inc.
Boldy Inc.: FDA-registered device maker in Donghae-si Gangwon, South Korea, 2 510(k) clearances
Boldy Inc. is registered with the FDA (registration 3043534331) in Donghae-si Gangwon, South Korea. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 3, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3043534331
- Address
- 177-20 Gongdan 1-ro, Donghae-si Gangwon, South Korea, 25798
- Owner or operator
- Boldy Inc. (10095067)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- January 20, 2026
- Registered through
- 2026
- Brand names listed
- HAPPY MOONDAY O Cotton Cover Pads Large, HAPPY MOONDAY O Cotton Cover Pads Medium, HAPPY MOONDAY O Cotton Cover Pads Small, Happy Moonday Digital Tampon Light, Happy Moonday Digital Tampon Regular, Happy Moonday Digital Tampon Super, Happy Moonday Easy Tampon Light, Happy Moonday Easy Tampon Regular and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pad, Menstrual, Unscented | HHD | 1 | Manufacturer | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| March 3, 2017 | K162746 | Ontex and other proprietary names | HEB | Substantially Equivalent | Ontex Bvba | accessdata.fda.gov |
| December 23, 2009 | K090819 | ONTEX TAMPON (UNSCENTED) | HEB | Substantially Equivalent | Ontex International NV | accessdata.fda.gov |
Compare with other makers
Updated March 3, 2017. 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.