Description of the goods Classification (CN code) Reasons

(1) (2) (3)

1. A plastic tube with a length of 142 cm with a plastic balloon at one end (so-called ‘balloon catheter’). The proximal segment of the catheter has a diameter of 0,63 mm and is made of hypotube material and coated with polytetrafluorethylene (PTFE). The distal segment of the catheter has a diameter in a range from 0,79 to 1,02 mm and is made of polyether bloc amide (PEBA) material and coated with hydrophilic material. The balloon has a length of 6 to 27 mm and a diameter of 2 to 5 mm. The tube has a Luer connection, an atraumatic (flexible) tip and 2 golden marker bands. The Luer connection makes it possible to connect the tube to an inflating device which is used to inflate the balloon. The atraumatic tip is used to move the catheter via a vein up through the body into the coronary artery. When the catheter is on the right place in the coronary artery, the balloon is inflated so that the fatty deposits (atherosclerotic plaque) are pressed against the wall of the vein. By compressing the plaque, the inside diameter of the vein increases. The marker bands make it possible to locate the exact position of the atraumatic tip in the body. The balloon catheter is removed from the body and discarded after treatment. The article is presented in packaging and is sterilised. (1) See image 1 9018 39 00 Classification is determined by general rules 1 and 6 for the interpretation of the Combined Nomenclature, and by the wording of CN codes 9018 and 9018 39 00. Due to its objective characteristics, namely the combination of the balloon, the atraumatic tip, the golden marker bands and the Luer connection, the tube can, upon presentation, be identified as an instrument or appliance of Chapter 90, used in medical sciences. Classification under heading 9021 is excluded as the tube is not implanted in the body to compensate for a defect or disability but it is removed after treatment. The product is therefore to be classified under CN code 9018 39 00 as catheters (see also the Harmonized System Explanatory Notes (HSEN) to heading 9018, Group (I)).

2. A plastic curved tube (so-called ‘guide catheter’) with an inner diameter ranging from 1,47 mm to 2,29 mm and a length of 100 cm with a radiopaque marker and an atraumatic (flexible) tip. The article comprises a double interlock knit flat section of stainless steel, encapsulated in plastic material (PEBA, polyphthalamide (PPA), Nylon) and it has a lubricant coating applied to the silicon inner surface of the guide catheter. The guide catheter enables access to the coronary artery through a vein. Other appliances can be directed by this guide catheter to the artery. The radiopaque marker makes it possible to locate the exact position of the atraumatic tip in the body. The guide catheter is removed from the body and discarded after treatment. The article is presented in packaging and is sterilised. (1) See image 2 9018 39 00 Classification is determined by general rules 1 and 6 for the interpretation of the Combined Nomenclature, and by the wording of CN codes 9018 and 9018 39 00. Due to its objective characteristics, namely the combination of the curve, the radiopaque marker, the atraumatic tip and the lubricant coating, the tube can, upon presentation, be identified as an instrument or appliance of Chapter 90, used in medical sciences. Classification under heading 9021 is excluded as the tube is not implanted in the body to compensate for a defect or disability but it is removed after treatment. The product is therefore to be classified under CN code 9018 39 00 as catheters (see also the HSEN to heading 9018, Group (I)).

3. A flexible metal wire (so-called ‘guide wire’) with a diameter of 0,35 mm, a length ranging from 180-300 cm, two radiopaque markers and a rounded tip. The wire is made of a metal alloy for biomedical use, with a proximal coating of PTFE and a distal coating of silicone or hydrophilic material. The radiopaque markers make it possible to locate the exact position of the wire in the body. The wire is used for guiding and positioning devices for interventions in the coronary artery. The guide wire is removed from the body and discarded after treatment. The article is presented in packaging and is sterilised. (1) See image 3 9018 39 00 Classification is determined by general rules 1 and 6 for the interpretation of the Combined Nomenclature, and by the wording of CN codes 9018 and 9018 39 00. Due to its objective characteristics, namely the combination of the design and the radiopaque markers, the wire can, upon presentation, be identified as an instrument or appliance of Chapter 90, used in medical sciences. Classification under heading 9021 is excluded as the wire is not implanted in the body to compensate for a defect or disability but it is removed after treatment. The product is therefore to be classified under CN code 9018 39 00 as wire guides (see also the HSEN to heading 9018 Group (I)).