Data / Medical devices / Taiwan / Icares Medicus, Inc.
Icares Medicus, Inc.: FDA-registered device maker in Zhubei Hsinchu(County), Taiwan, 1 510(k) clearance
Icares Medicus, Inc. is registered with the FDA (registration 3009646326) in Zhubei Hsinchu(County), Taiwan. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 4, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009646326
- Address
- 4F., No.12 & No.16, Sec. 2, Shengyi Road. Zhubei City, Hsinchu County, Taiwan, R.O.C., Zhubei Hsinchu(County), Taiwan, 30261
- Owner or operator
- ICARES Medicus, Inc. (10047474)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- September 14, 2014
- Registered through
- 2027
- Brand names listed
- BL-Cart IOL Delivery Cartridge, bioli IOL Delivery System, lioli IOL Delivery System, pioli IOL Delivery System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Folders And Injectors, Intraocular Lens (Iol) | MSS | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Lens, Guide, Intraocular | KYB | 1 | Contract 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 |
|---|---|---|---|---|---|---|
| June 4, 2020 | K200057 | bioli lOL Delivery System | MSS | Substantially Equivalent | Ast Products, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 4, 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.