Regulatory

Calbiotech is an FDA registered, ISO 13485:2003 CMDCAS Certified Company.

The management of Calbiotech has made a commitment to consistently provide customers with superior products and services that meet or exceed quality and regulatory requirements of the industry through continuous advancement.

Click to view our certifications below:

• Certificate of Exportability 801(e)(1)
• Certificate to Foreign Government
• Device Manufacturing License
• ISO 13485-2003 CMDCAS
• RIA License
• EU Declaration of Conformity