Products About Unitract® Syringes Regulatory Information

Regulatory and Certification Information


International GMP Certification

NSAI ISO Certificate MD19.4629 NSAI ISO Certificate MD19.4629 
NSAI CMDCAS Certificate CM19.4629 NSAI CMDCAS Certificate CM19.4629 

Patents

Patents link Patents link

Regulatory

NSAI CE Certificate 252.819 NSAI CE Certificate 252.819
Canada SafeSyringe Licence Canada Safe Syringe License 
Canada Insulin Syringe License Canada Insulin Syringe License
Canada Tuberculin Syringe License Canada Tuberculin Syringe License
ARTG License ARTG License

 

  • FDA 510(k) #K093400 Insulin Syringe
  • FDA 510(k) #K100998 Tuberculin Syringe
  • FDA Registered Facility #3007710720


Unitract Availability Chart


Name of Product Product Code Regulatory Approval for Sale
1mL Unitract Insulin Syringe 27Gx1/2” (China) 112BY1-1 USA, EU*, Canada, Australia & NZ, Switzerland
1mL Unitract Insulin Syringe 27G x1/2” (USA) 112BY2-1 USA, EU*, Canada
1mL Unitract Insulin Syringe 29G x1/2” (China) 112CY1-1 USA, EU*, Canada, Australia & NZ, Switzerland
1mL Unitract Insulin Syringe 29G x1/2” (USA) 112CY2-1 USA, EU*, Canada
1mL Unitract Tuberculin Syringe 27G (USA) 132BY2-1 USA, EU*, Canada
1mL Unitract Safe Syringe 27G x1/2” (China) 10001 EU*, Canada, Australia & NZ, Switzerland

* Austria; Belgium; Bulgaria; Cyprus; Czech Rep;  Denmark; Estonia; Finland; France; Germany;  Greece; Hungary; Ireland; Italy; Latvia; Lithuania; Luxembourg; Malta; Netherlands; Poland; Portugal; Romania; Slovakia; Slovenia; Spain; Sweden; UK