Certifications Health-Chem Diagnostics LLC is a US FDA & ISO Certified facility ISO/FDIS/CMDCAS 13485:2003 certified - Registration #FM77504 CE Mark - TNO 0336 - Health-Chem can provide CE marking through our Notified Body TNO. Most private label clients can be supplied with complete technical files for obtaining their own CE mark. FDA REGISTERED: No. 1048532 FDA Registered Products FDA, Certificate To Foreign Government, Page 1  Page 2 CANADIAN LICENSE: LN/NH 65977 - Health Canada