Alliance International Co., Ltd.
TW Last updated 22 Oct 2026
- Devices
- 2
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
I-Qare Ds-W Blood Glucose Monitoring System Ref K132663
Ds-A Blood Glucose Monitoring System Ref K082965
FDA establishments
- Alliance International Corp. Ltd. CHEUNG SHA WAN, KOWLOON · HK FEI 3003069829
What Alliance International Co., Ltd. makes
Alliance International Co., Ltd. manufactures blood glucose monitoring systems, including the I-QARE DS-W and DS-A devices, designed for diabetes management and continuous glucose level tracking.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Frequently asked questions
What types of medical devices does Alliance International Co., Ltd. manufacture?
Alliance International Co., Ltd. specializes in blood glucose monitoring systems, such as the I-QARE DS-W and DS-A devices. These products are developed for diabetes management, helping users track glucose levels to support their health.
Where is Alliance International Co., Ltd. based?
The company is headquartered in the United States. This location allows it to operate within the regulatory framework of the FDA, which governs its device classifications and submissions.
Which regulatory registries list Alliance International Co., Ltd.’s devices?
The company’s blood glucose monitoring systems, such as the I-QARE DS-W and DS-A, are included in the FDA’s 510(k) clearance registry. This registry tracks devices that have undergone the 510(k) premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device.
How are Alliance International Co., Ltd.’s devices classified under FDA regulations?
Alliance International Co., Ltd.’s blood glucose monitoring systems fall under Class II classification by the FDA. This classification applies to devices that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness.
Information
- Country
- TW