Data / Medical devices / Taiwan / Alliance International Medical Co., Ltd.
Alliance International Medical Co., Ltd.: FDA-registered device maker in New Taipei City, Taiwan, 2 510(k) clearances
Alliance International Medical Co., Ltd. is registered with the FDA (registration 3006532271) in New Taipei City, Taiwan. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 20, 2015. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3006532271
- Address
- No.54, Yingtao Rd., Yingge Dist., New Taipei City, Taiwan, 23942
- Owner or operator
- ALLIANCE INTERNATIONAL MEDICAL CO., LTD. (9099902)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- March 19, 2010
- Registered through
- 2027
- Brand names listed
- DS-A Blood Glucose Monitoring Syste, DS-A Sterile Lancets, DS-W Disposable Lancets, Glucose Monitoring System, Powered Toothbrush
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Glucose Oxidase, Glucose | CGA | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Contract manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | 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 |
|---|---|---|---|---|---|---|
| April 20, 2015 | K132663 | I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Alliance International Co., Ltd. | accessdata.fda.gov |
| December 7, 2009 | K082965 | DS-A BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | Alliance International Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Toothbrush, Powered
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Glucose Oxidase, Glucose
Updated April 20, 2015. 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.