Used materials 
Needle cap: PP Cannula: Stainless steel SUS304 Gasket: Latex free rubber Barrel, Plunger: PP Adhesive: UV Adhesive Needle and Barrel Lubricant: Silicone oil

Labeling 
on each unit are written the reference, the lot/serial number, the sterilization method and the expiry date if applicable

medical device 

• MD class : IIa
• MD notified body : 2797
• EU directive/regulation : Directive
• annexe : V

sterile 

• sterile : yes
• sterilization method : ethylene oxide

conformity 

• Sterilization of health-care products - Ethylene oxide - Requiremnets for the development, validation and routine control of a sterilization process for medical devices
• Sterile hypodermic syringes for single use - Part 1 : syringes for manual use
• Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management procee
• Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
• Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements