Data / Medical devices / Taiwan / Ixensor Co Ltd
Ixensor Co Ltd: FDA-registered device maker in Taipei, Taiwan, 3 510(k) clearances
Ixensor Co Ltd is registered with the FDA (registration 3011061417) in Taipei, Taiwan. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 29, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011061417
- Address
- 11492 6F., No.9, Aly. 2, Ln. 35, Jihu Rd., Neihu Dist, Taipei, Taiwan, 114
- Owner or operator
- iXensor Co Ltd (10048224)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- December 18, 2014
- Registered through
- 2026
- Brand names listed
- CVSHealth, Eveline, PixoTest, PixoTest Vision Analysis System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Manufacturer | accessdata.fda.gov |
| Assay, Glycosylated Hemoglobin | LCP | 2 | Manufacturer | accessdata.fda.gov |
| Colorimetric Method, Triglycerides | JGY | 1 | Manufacturer | accessdata.fda.gov |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | 1 | Manufacturer | accessdata.fda.gov |
| Ldl & Vldl Precipitation, Hdl | LBR | 1 | Manufacturer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Manufacturer | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | 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 |
|---|---|---|---|---|---|---|
| October 29, 2019 | K192369 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | LCP | Substantially Equivalent | Ixensor Co, Ltd. | accessdata.fda.gov |
| April 12, 2019 | K181915 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | LCP | Substantially Equivalent | Ixensor Co, Ltd. | accessdata.fda.gov |
| November 2, 2017 | K163087 | PixoTest Blood Glucose Monitoring System | NBW | Substantially Equivalent | Ixensor Company , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilatory Effort Recorder
- All makers of Assay, Glycosylated Hemoglobin
- All makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Ldl & Vldl Precipitation, Hdl
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
Updated October 29, 2019. 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.