Data / Medical devices / Taiwan / Bonasse Ent. Co., Ltd.
Bonasse Ent. Co., Ltd.: FDA-registered device maker in CHUNGLI CITY Taoyuan, Taiwan, 2 510(k) clearances
Bonasse Ent. Co., Ltd. is registered with the FDA (registration 1000375210) in CHUNGLI CITY Taoyuan, Taiwan. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 3, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000375210
- Address
- No.11-1 Song Chiang S. Road, Chungli Industrial Park, CHUNGLI CITY Taoyuan, Taiwan, --
- Owner or operator
- BONASSE ENT. CO., LTD. (9029965)
- Roles
- Manufacturer
- First device listed
- December 18, 2007
- Registered through
- 2026
- Brand names listed
- Bonasse Contact Lens Case, Bonasse Dispenser, Bonasse Lens remover
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Case, Contact Lens | LRX | 2 | Manufacturer | accessdata.fda.gov |
| Dispenser, Solid Medication | NXB | 1 | Manufacturer | accessdata.fda.gov |
| Inserter/Remover Contact Lens | KYE | 1 | 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 |
|---|---|---|---|---|---|---|
| April 3, 2013 | K130285 | PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS | LRX | Substantially Equivalent | The Lagado Corp. | accessdata.fda.gov |
| June 6, 2000 | K991206 | BONASSE CONTACT LENS CASE | LRX | Substantially Equivalent | Bonasse Ent. Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Dispenser, Solid Medication
- All makers of Case, Contact Lens
- All makers of Inserter/Remover Contact Lens
Updated April 3, 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.