Data / Medical devices / Taiwan / Oneness Biotech Co., Ltd.
Oneness Biotech Co., Ltd.: FDA-registered device maker in Pingtung County, Taiwan, 4 510(k) clearances
Oneness Biotech Co., Ltd. is registered with the FDA (registration 3015077448) in Pingtung County, Taiwan. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated June 17, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015077448
- Address
- No.8, Tangchang Rd., Nanchou Township, Pingtung County, Taiwan, 926
- Owner or operator
- Oneness Biotech Co., Ltd (10087222)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 31, 2023
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Complaint file establishment, 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 17, 2026 | K261638 | Bonvadis® | FRO | Substantially Equivalent | Oneness Biotech Co., Ltd. | accessdata.fda.gov |
| June 9, 2025 | K251093 | Bonvadis® | FRO | Substantially Equivalent | Oneness Biotech Co., Ltd. | accessdata.fda.gov |
| May 22, 2024 | K232655 | Bonvadis® | FRO | Substantially Equivalent | Stemcyte, Inc. | accessdata.fda.gov |
| August 19, 2022 | K212554 | Bonvadis Topical Cream | FRO | Substantially Equivalent | Stemcyte, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 17, 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.