Data / Medical devices / Taiwan / Hedonist Biochemical Technologies Co., Ltd.
Hedonist Biochemical Technologies Co., Ltd.: FDA-registered device maker in Taipei, Taiwan, 2 510(k) clearances
Hedonist Biochemical Technologies Co., Ltd. is registered with the FDA (registration 3003524577) in Taipei, Taiwan. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated July 7, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003524577
- Address
- 6F, No. 208, Ruei-Guang Road, Taipei, Taiwan, 114
- Owner or operator
- HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD. (9052873)
- Roles
- Manufacturer
- First device listed
- December 26, 2007
- Registered through
- 2026
- Brand names listed
- Suile Ointment Wound Dressing, Suile Wound Dressing
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | 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 |
|---|---|---|---|---|---|---|
| July 7, 2004 | K041013 | SUILE OINTMENT WOUND DRESSING | FRO | Substantially Equivalent | Hedonist Biochemical Technologies Co., Ltd. | accessdata.fda.gov |
| July 8, 2003 | K022967 | SUILE WOUND DRESSING | FRO | Substantially Equivalent | Hedonist Biochemical Technologies Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 7, 2004. 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.