Data / Medical devices / Taiwan / Bioptik Technology, Inc.
Bioptik Technology, Inc.: FDA-registered device maker in Jhunan Township Miaoli, Taiwan, 1 510(k) clearance
Bioptik Technology, Inc. is registered with the FDA (registration 3005706626) in Jhunan Township Miaoli, Taiwan. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 1, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005706626
- Address
- No.188, Jhonghua South Road, Gongguan Village, Jhunan Township Miaoli, Taiwan, 35057
- Owner or operator
- Bioptik Technology, Inc. (10023609)
- Roles
- Manufacturer
- First device listed
- December 5, 2007
- Registered through
- 2026
- Brand names listed
- EasyMate
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Manufacturer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 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 |
|---|---|---|---|---|---|---|
| March 1, 2006 | K053312 | EASYMATE BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Bioptik Technology, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Multi-Analyte Controls, All Kinds (Assayed)
- All makers of System, Test, Blood Glucose, Over The Counter
Updated March 1, 2006. 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.