Data / Medical devices / Taiwan / Gostar Co., Ltd.
Gostar Co., Ltd.: FDA-registered device maker in New Taipei City, Taiwan, 2 510(k) clearances
Gostar Co., Ltd. is registered with the FDA (registration 3030626362) in New Taipei City, Taiwan. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 19, 2023. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3030626362
- Address
- 2F., No. 65, Wuquan 7th Rd., Wugu Dist., New Taipei City, Taiwan, 248020
- Owner or operator
- GOSTAR CO., LTD. (10090367)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 19, 2024
- Registered through
- 2027
- Brand names listed
- FORA LANCING DEVICE ; FORA STERILE LANCETS, FORA Spiro10b Peak Flow Meter, FORA gojji LANCING DEVICE ; FORA gojji STERILE LANCETS, LIVE TULA Sterile lancets, TD-5010 Lancing Device ; TD-THIN Sterile Lancets, TD-5010 Lancing Device and TD-5084 Sterile Lancets, TD-5011 Lancing Device ; TD-THIN Sterile Lancets, TD-7301 Peak Flow Meter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Meter, Peak Flow, Spirometry | BZH | 2 | Manufacturer | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Specification developer | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 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 |
|---|---|---|---|---|---|---|
| December 19, 2023 | K222810 | TD-7301 Peak Flow meter | BZH | Substantially Equivalent | Gostar Co., Ltd. | accessdata.fda.gov |
| January 20, 2023 | K221419 | TD-5010 Lancing Device and TD-5084 Sterile Lancets | QRL | Substantially Equivalent | Gostar Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Meter, Peak Flow, Spirometry
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Updated December 19, 2023. 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.