Data / Medical devices / Taiwan / Sunphoria Co., Ltd.
Sunphoria Co., Ltd.: FDA-registered device maker in Taipei City, Taiwan, 1 510(k) clearance
Sunphoria Co., Ltd. is registered with the FDA (registration 3016579901) in Taipei City, Taiwan. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 14, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016579901
- Address
- 12F-1, No.51, Hengyang Rd., Zhongzheng Dist., Taipei City, Taiwan, 10045
- Owner or operator
- Sunphoria Co., Ltd. (10062637)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- February 24, 2020
- Registered through
- 2026
- Brand names listed
- AHC Platelet Concentrate Separator, BAPA Tube for T-TAS 01
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Platelet And Plasma Separator For Bone Graft Handling | ORG | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Automated Platelet Aggregation | JOZ | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| February 14, 2020 | K191364 | T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01 | JOZ | Substantially Equivalent | Fujimori Kogyo, Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Automated Platelet Aggregation
- All makers of Platelet And Plasma Separator For Bone Graft Handling
Updated February 14, 2020. 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.