Products About Unitract™ Syringes Regulatory Information

Regulatory and Certification Information


International GMP Certification

International GMP Certification ISO 13485:2003 /CMDCAS Certificate

Patents

Patents link Patents link

Regulatory

CE Mark (Includes EU & EFTA) CE Mark (Includes EU & EFTA)
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