Biotron Certifications

FDA Device Establishment Registration No.: 1824721
Establishment Type: Manufacturer, Domestic distributor, Repackager and Relabeler EIN # 33-0695035
DUNS #962606505
SBA – Small Business
Small Disadvantaged Business Certification # P068138-0007342
HUB Zone – Qualified
Minority Owned Business – Certification
PRO-Net Registration # P0215953
Defense Logistics Agency – Trading Partner Registration # CCR (KUZBHC)
CAGE CODE # (O)1RSUO
SIN CODE #555
NAIC/SIC CODE # 3253 13/42512
Government Service Administration FSS Contractor – Approved
GSA Advantage – Approved
Certificate To Foreign Government -(current)
Certificate of Exportability (current)
IVD – CE Mark Certification
ISO 9001 and ISO 13485 Certification
FDA Approved Medical Device 510(K) List (available)