They are manufactured under a Quality Management System in accordance with the standards PN-EN ISO 13485:2016-04, PN-EN ISO 9001:2015, and the Medical Directive 93/42/EEC, and are registered with the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
The single-use two-piece syringes consist of the following components:
- a Luer conical connector,
- a clear, indelible, double measurement scale,
- przezroczysty cylinder (korpus) strzykawki o pojemności 5 ml z poszerzoną skalą do 6 ml,
- a syringe plunger in white/milky color,
- a double flange to prevent the plunger from falling out,
- markings on the body: manufacturer's logo, product name, and a symbol indicating single use only.
The single-use two-piece syringes are:
- packed in quantities of 100 pieces,
- pakowane w opakowanie jednostkowe typu blister-pack w kolorze czerwonym
- opakowanie zbiorcze, karton z tektury falistej – 2 000 szt.
- phthalate-free — symbol on the individual packaging.
The two-piece syringes are entirely manufactured, packaged, and sterilized in Poland.