Data / Medical devices / South Korea / Billions Co.,ltd
Billions Co.,ltd: FDA-registered device maker in Chungcheongbuk-do Chungbuk, South Korea, 6 510(k) clearances
Billions Co.,ltd is registered with the FDA (registration 9612266) in Chungcheongbuk-do Chungbuk, South Korea. It lists 1 device type. The FDA files 6 510(k) clearances under its listings, the newest dated November 15, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9612266
- FEI number
- 3002808112
- Address
- 473-3 Gwangjang-Ro Jeungpyeong-Eup, Jeungpyeong-Gun, Chungcheongbuk-do Chungbuk, South Korea, 06084
- Owner or operator
- BILLIONS CO.,LTD (8040159)
- Roles
- Manufacturer
- First device listed
- February 5, 2008
- Registered through
- 2026
- Brand names listed
- Viking Performance Long Love (Ribbed Type)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 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 |
|---|---|---|---|---|---|---|
| November 15, 2007 | K072747 | UNIDUS MAGNUM MALE LATEX CONDOM | HIS | Substantially Equivalent | Unidus Corp. | accessdata.fda.gov |
| December 23, 2003 | K033541 | LONG LOVE CONDOM | HIS | Substantially Equivalent | Unidus Corp. | accessdata.fda.gov |
| December 13, 2002 | K023176 | UNDUS MALE LATEX CONDOM (WITH FLAVORING) | HIS | Substantially Equivalent | Unidus Corp. | accessdata.fda.gov |
| December 13, 2002 | K023175 | UNIDUS MALE LATEX CONDOM (WITH COLOR AND FLAVORING) | HIS | Substantially Equivalent | Unidus Corp. | accessdata.fda.gov |
| December 13, 2002 | K023129 | UNIDUS MALE LATEX CONDOM (YELLOW, PINK, GREEN & BLACK) | HIS | Substantially Equivalent | Unidus Corp. | accessdata.fda.gov |
| December 12, 2002 | K023059 | UNIDUS MALE LATEX CONDOM | HIS | Substantially Equivalent | Unidus Corp. | accessdata.fda.gov |
Compare with other makers
Updated November 15, 2007. 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.