Data / Medical devices / Taiwan / Medifun Corporation
Medifun Corporation: FDA-registered device maker in Taichung, Taiwan, 1 510(k) clearance
Medifun Corporation is registered with the FDA (registration 3002680783) in Taichung, Taiwan. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 15, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002680783
- Address
- 4F-1, 4F-9, 4F-10, No.99, Jingke S. Rd., Nantun Dist., Taichung, Taiwan, 40818
- Owner or operator
- Medifun Corporation (10050917)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- March 18, 2024
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Contract manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| August 15, 2024 | K241750 | Medifun Safety Lancet ( MSL1 series) | FMK | Substantially Equivalent | Medifun Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Updated August 15, 2024. 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.