Data / Medical devices / Taiwan / Flat Medical Co., Ltd.
Flat Medical Co., Ltd.: FDA-registered device maker in Taipei, Taiwan, 3 510(k) clearances
Flat Medical Co., Ltd. is registered with the FDA (registration 3014716786) in Taipei, Taiwan. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 21, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014716786
- Address
- 12F.-2, No. 206, Sec. 2, Nanjing E. Rd., Zhongshan Dist., Taipei 104496, Taiwan, Taipei, Taiwan, 104496
- Owner or operator
- Flat Medical Co., Ltd. (10060448)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Specification developer
- First device listed
- May 29, 2019
- Registered through
- 2026
- Brand names listed
- EpiFaith CV, EpiFaith Syringe (Luer Slip), EpiFaith Syringe (Luer Lock), EpiFaith Syringe (NRFit), EpiFaith Syringe (Luer Slip), EpiFaith Syringe (NRFit)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Syringe, Piston | FMF | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Complaint file establishment, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| September 21, 2022 | K212615 | EpiFaith CV | DQX | Substantially Equivalent | Flat Medical Co., Ltd. | accessdata.fda.gov |
| September 27, 2019 | K192421 | EpiFaith Syringe | FMF | Substantially Equivalent | Flat Medical Co., Ltd. | accessdata.fda.gov |
| April 5, 2019 | K182268 | EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) | FMF | Substantially Equivalent | Flat Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 21, 2022. 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.