Data / Medical devices / Taiwan / Taiwan Biotech Co., Ltd.
Taiwan Biotech Co., Ltd.: FDA-registered device maker in Taoyuan, Taiwan, 3 510(k) clearances
Taiwan Biotech Co., Ltd. is registered with the FDA (registration 9617489) in Taoyuan, Taiwan. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 11, 2016. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9617489
- FEI number
- 3003598505
- Address
- 22 Chieh Shou RD., Taoyuan, Taiwan, 330
- Owner or operator
- TAIWAN BIOTECH CO., LTD. (9036218)
- Roles
- Manufacturer
- First device listed
- November 21, 2007
- Registered through
- 2027
- Brand names listed
- Eye-Cept Rewetting Drops, LensGiene, LensGiene Sterile Saline Solution
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Soft Lens Products | LPN | 2 | Manufacturer | accessdata.fda.gov |
| Products, Contact Lens Care, Rigid Gas Permeable | MRC | 2 | 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 11, 2016 | K161622 | LensGiene Sterile Saline Solution | LPN | Substantially Equivalent | Optics Laboratory, Inc. | accessdata.fda.gov |
| November 1, 2011 | K110221 | EYE-CEPT STERILE SALINE SOLUTION | LPN | Substantially Equivalent | Optics Laboratory, Inc. | accessdata.fda.gov |
| July 1, 2005 | K041008 | EYE-CEPT REWETTING DROPS | LPN | Substantially Equivalent | Optics Laboratory, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Soft Lens Products
- All makers of Products, Contact Lens Care, Rigid Gas Permeable
Updated August 11, 2016. 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.