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The latest technology

Our engineering team constantly strive to apply the latest technologies to create products that are precise as they are easy to use, thereby creating the most cost efficient solution to our partners. We have models that give results in seconds and require blood size less than a needle tip, while still maintain low cost to our partners. We also successfully applied our patented biosensor platforms into other diagnostic interests, such as uric acid and lactate measuring in whole blood.

 

Volume production and top quality

Backed by a 210-member production staff, we manufacture up to 40,000 monitors and 22,000,000 test strips monthly. To satisfy our quality-conscious clients in America and Europe, our processes are ISO9001:2000, ISO13485 and EN46001 certified, and our products come with CE, FDA,GMP and IVDD approvals. We offer samples in a week, and 30-day deliveries. For more on our ApexBio brand, or for OEM/ODM inquiries, contact us today.

Regulatory Authority/ Registrar

Compliance Regulation

Compliance Number

TUV

ISO 9001:2000
NA

ISO 13485:2003

NA
FDA 510 (k)
K980573
510 (k)
K011233

510 (k)

K002621

TUV

IVDD Directive

CE 0197