Data / Medical devices / Taiwan / Prosben, Inc.
Prosben, Inc.: FDA-registered device maker in Taipei City, Taiwan, 1 510(k) clearance
Prosben, Inc. is registered with the FDA (registration 8022656) in Taipei City, Taiwan. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 31, 2013. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8022656
- FEI number
- 3005668459
- Address
- 8F., No. 58, Sec. 3 Minquan E. Rd., Zhongshan Dist., Taipei City, Taiwan, 104678
- Owner or operator
- PROSBEN, INC. (8022656)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- July 3, 2013
- Registered through
- 2027
- Brand names listed
- Hand Cleaner, Screen / Lens Wipe, Lens Cleaner, Anti-Fog Products
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Case, Contact Lens | LRX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pad, Alcohol, Device Disinfectant | LKB | U | 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 |
|---|---|---|---|---|---|---|
| May 31, 2013 | K122700 | PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES | LRX | Substantially Equivalent | Prosben, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Disinfectant, Medical Devices
- All makers of Case, Contact Lens
- All makers of Pad, Alcohol, Device Disinfectant
Updated May 31, 2013. 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.