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BIOTRONIK PASSEO-35 XEO PERIPHERAL DILATATION CATHETER - HSA Registration DE0505152

Access comprehensive regulatory information for BIOTRONIK PASSEO-35 XEO PERIPHERAL DILATATION CATHETER in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0505152 and owned by Biotronik AG. The device was registered on November 18, 2020.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS D
DE0505152
BIOTRONIK PASSEO-35 XEO PERIPHERAL DILATATION CATHETER
HSA Registration Number: DE0505152
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Product Description

is indicated to dilate stenosis in the iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Passeo-35 Xeo is also recommended for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0505152
Registration Date
November 18, 2020
Change Notification Approval Date
April 07, 2025
Retention Due Date
November 17, 2025
Product Owner
Short Name
Biotronik
Address
Ackerstrasse 6, 8180 Bülach, SWITZERLAND
Registrant
Address
165 KALLANG WAY, #07-00, SINGAPORE 349257
Importer
Address
165 KALLANG WAY, #07-00, SINGAPORE 349257
Model Information
Model Name(s)
Passeo-35 Xeo 3/20/90 Passeo-35 Xeo 4/20/90 Passeo-35 Xeo 5/20/90 Passeo-35 Xeo 6/20/90 Passeo-35 Xeo 7/20/90 Passeo-35 Xeo 8/20/90 Passeo-35 Xeo 9/20/90 Passeo-35 Xeo 10/20/90 Passeo-35 Xeo 3/40/90 Passeo-35 Xeo 4/40/90 Passeo-35 Xeo 5/40/90 Passeo-35 Xeo 6/40/90 Passeo-35 Xeo 7/40/90 Passeo-35 Xeo 8/40/90 Passeo-35 Xeo 9/40/90 Passeo-35 Xeo 10/40/90 Passeo-35 Xeo 12/40/90 Passeo-35 Xeo 3/60/90 Passeo-35 Xeo 4/60/90 Passeo-35 Xeo 5/60/90 Passeo-35 Xeo 6/60/90 Passeo-35 Xeo 7/60/90 Passeo-35 Xeo 8/60/90 Passeo-35 Xeo 9/60/90 Passeo-35 Xeo 10/60/90 Passeo-35 Xeo 12/60/90 Passeo-35 Xeo 3/80/90 Passeo-35 Xeo 4/80/90 Passeo-35 Xeo 5/80/90 Passeo-35 Xeo 6/80/90 Passeo-35 Xeo 7/80/90 Passeo-35 Xeo 8/80/90 Passeo-35 Xeo 9/80/90 Passeo-35 Xeo 10/80/90 Passeo-35 Xeo 12/80/90 Passeo-35 Xeo 3/100/90 Passeo-35 Xeo 4/100/90 Passeo-35 Xeo 5/100/90 Passeo-35 Xeo 6/100/90 Passeo-35 Xeo 7/100/90 Passeo-35 Xeo 8/100/90 Passeo-35 Xeo 9/100/90 Passeo-35 Xeo 10/100/90 Passeo-35 Xeo 12/100/90 Passeo-35 Xeo 3/120/90 Passeo-35 Xeo 4/120/90 Passeo-35 Xeo 5/120/90 Passeo-35 Xeo 6/120/90 Passeo-35 Xeo 7/120/90 Passeo-35 Xeo 8/120/90 Passeo-35 Xeo 9/120/90 Passeo-35 Xeo 10/120/90 Passeo-35 Xeo 12/120/90 Passeo-35 Xeo 3/150/90 Passeo-35 Xeo 4/150/90 Passeo-35 Xeo 5/150/90 Passeo-35 Xeo 6/150/90 Passeo-35 Xeo 7/150/90 Passeo-35 Xeo 3/170/90 Passeo-35 Xeo 4/170/90 Passeo-35 Xeo 5/170/90 Passeo-35 Xeo 6/170/90 Passeo-35 Xeo 7/170/90 Passeo-35 Xeo 3/200/90 Passeo-35 Xeo 4/200/90 Passeo-35 Xeo 5/200/90 Passeo-35 Xeo 6/200/90 Passeo-35 Xeo 7/200/90 Passeo-35 Xeo 3/250/90 Passeo-35 Xeo 4/250/90 Passeo-35 Xeo 5/250/90 Passeo-35 Xeo 6/250/90 Passeo-35 Xeo 7/250/90 Passeo-35 Xeo 3/20/130 Passeo-35 Xeo 4/20/130 Passeo-35 Xeo 5/20/130 Passeo-35 Xeo 6/20/130 Passeo-35 Xeo 7/20/130 Passeo-35 Xeo 8/20/130 Passeo-35 Xeo 9/20/130 Passeo-35 Xeo 10/20/130 Passeo-35 Xeo 3/40/130 Passeo-35 Xeo 4/40/130 Passeo-35 Xeo 5/40/130 Passeo-35 Xeo 6/40/130 Passeo-35 Xeo 7/40/130 Passeo-35 Xeo 8/40/130 Passeo-35 Xeo 9/40/130 Passeo-35 Xeo 10/40/130 Passeo-35 Xeo 12/40/130 Passeo-35 Xeo 3/60/130 Passeo-35 Xeo 4/60/130 Passeo-35 Xeo 5/60/130 Passeo-35 Xeo 6/60/130 Passeo-35 Xeo 7/60/130 Passeo-35 Xeo 8/60/130 Passeo-35 Xeo 9/60/130 Passeo-35 Xeo 10/60/130 Passeo-35 Xeo 12/60/130 Passeo-35 Xeo 3/80/130 Passeo-35 Xeo 4/80/130 Passeo-35 Xeo 5/80/130 Passeo-35 Xeo 6/80/130 Passeo-35 Xeo 7/80/130 Passeo-35 Xeo 8/80/130 Passeo-35 Xeo 9/80/130 Passeo-35 Xeo 10/80/130 Passeo-35 Xeo 12/80/130 Passeo-35 Xeo 3/100/130 Passeo-35 Xeo 4/100/130 Passeo-35 Xeo 5/100/130 Passeo-35 Xeo 6/100/130 Passeo-35 Xeo 7/100/130 Passeo-35 Xeo 8/100/130 Passeo-35 Xeo 9/100/130 Passeo-35 Xeo 10/100/130 Passeo-35 Xeo 12/100/130 Passeo-35 Xeo 3/120/130 Passeo-35 Xeo 4/120/130 Passeo-35 Xeo 5/120/130 Passeo-35 Xeo 6/120/130 Passeo-35 Xeo 7/120/130 Passeo-35 Xeo 8/120/130 Passeo-35 Xeo 9/120/130 Passeo-35 Xeo 10/120/130 Passeo-35 Xeo 12/120/130 Passeo-35 Xeo 3/150/130 Passeo-35 Xeo 4/150/130 Passeo-35 Xeo 5/150/130 Passeo-35 Xeo 6/150/130 Passeo-35 Xeo 7/150/130 Passeo-35 Xeo 3/170/130 Passeo-35 Xeo 4/170/130 Passeo-35 Xeo 5/170/130 Passeo-35 Xeo 6/170/130 Passeo-35 Xeo 7/170/130 Passeo-35 Xeo 3/200/130 Passeo-35 Xeo 4/200/130 Passeo-35 Xeo 5/200/130 Passeo-35 Xeo 6/200/130 Passeo-35 Xeo 7/200/130 Passeo-35 Xeo 3/250/130 Passeo-35 Xeo 4/250/130 Passeo-35 Xeo 5/250/130 Passeo-35 Xeo 6/250/130 Passeo-35 Xeo 7/250/130 Passeo-35 Xeo 3/20/170 Passeo-35 Xeo 4/20/170 Passeo-35 Xeo 5/20/170 Passeo-35 Xeo 6/20/170 Passeo-35 Xeo 7/20/170 Passeo-35 Xeo 8/20/170 Passeo-35 Xeo 9/20/170 Passeo-35 Xeo 10/20/170 Passeo-35 Xeo 3/40/170 Passeo-35 Xeo 4/40/170 Passeo-35 Xeo 5/40/170 Passeo-35 Xeo 6/40/170 Passeo-35 Xeo 7/40/170 Passeo-35 Xeo 8/40/170 Passeo-35 Xeo 9/40/170 Passeo-35 Xeo 10/40/170 Passeo-35 Xeo 12/40/170 Passeo-35 Xeo 3/60/170 Passeo-35 Xeo 4/60/170 Passeo-35 Xeo 5/60/170 Passeo-35 Xeo 6/60/170 Passeo-35 Xeo 7/60/170 Passeo-35 Xeo 8/60/170 Passeo-35 Xeo 9/60/170 Passeo-35 Xeo 10/60/170 Passeo-35 Xeo 12/60/170 Passeo-35 Xeo 3/80/170 Passeo-35 Xeo 4/80/170 Passeo-35 Xeo 5/80/170 Passeo-35 Xeo 6/80/170 Passeo-35 Xeo 7/80/170 Passeo-35 Xeo 8/80/170 Passeo-35 Xeo 9/80/170 Passeo-35 Xeo 10/80/170 Passeo-35 Xeo 12/80/170 Passeo-35 Xeo 3/100/170 Passeo-35 Xeo 4/100/170 Passeo-35 Xeo 5/100/170 Passeo-35 Xeo 6/100/170 Passeo-35 Xeo 7/100/170 Passeo-35 Xeo 8/100/170 Passeo-35 Xeo 9/100/170 Passeo-35 Xeo 10/100/170 Passeo-35 Xeo 12/100/170 Passeo-35 Xeo 3/120/170 Passeo-35 Xeo 4/120/170 Passeo-35 Xeo 5/120/170 Passeo-35 Xeo 6/120/170 Passeo-35 Xeo 7/120/170 Passeo-35 Xeo 8/120/170 Passeo-35 Xeo 9/120/170 Passeo-35 Xeo 10/120/170 Passeo-35 Xeo 12/120/170 Passeo-35 Xeo 3/150/170 Passeo-35 Xeo 4/150/170 Passeo-35 Xeo 5/150/170 Passeo-35 Xeo 6/150/170 Passeo-35 Xeo 7/150/170 Passeo-35 Xeo 3/170/170 Passeo-35 Xeo 4/170/170 Passeo-35 Xeo 5/170/170 Passeo-35 Xeo 6/170/170 Passeo-35 Xeo 7/170/170 Passeo-35 Xeo 3/200/170 Passeo-35 Xeo 4/200/170 Passeo-35 Xeo 5/200/170 Passeo-35 Xeo 6/200/170 Passeo-35 Xeo 7/200/170 Passeo-35 Xeo 3/250/170 Passeo-35 Xeo 4/250/170 Passeo-35 Xeo 5/250/170 Passeo-35 Xeo 6/250/170 Passeo-35 Xeo 7/250/170
Model Identifier(s)
428777 428778 428779 428780 428781 428782 428783 428784 428786 428787 428788 428789 428790 428791 428792 428793 428794 428795 428796 428797 428798 428799 428800 428801 428802 428803 428804 428805 428806 428807 428808 428809 428810 428811 428812 428813 428814 428815 428816 428817 428818 428819 428820 428821 428822 428823 428824 428825 428826 428827 428828 428829 428830 428831 428832 428833 428834 428835 428836 428837 428838 428839 428840 428841 428842 428843 428844 428845 428846 428847 428848 428849 428850 428851 428852 428853 428854 428855 428856 428857 428858 428860 428861 428862 428863 428864 428865 428866 428867 428868 428869 428870 428871 428872 428873 428874 428875 428876 428877 428878 428879 428880 428881 428882 428883 428884 428885 428886 428887 428888 428889 428890 428891 428892 428893 428894 428895 428896 428897 428898 428899 428900 428901 428902 428903 428904 428905 428906 428907 428908 428909 428910 428911 428912 428913 428914 428915 428916 428917 428918 428919 428920 428921 428922 428923 428924 428925 428926 428927 428928 428929 428930 428931 428932 428934 428935 428936 428937 428938 428939 428940 428941 428942 428943 428944 428945 428946 428947 428948 428949 428950 428951 428952 428953 428954 428955 428956 428957 428958 428959 428960 428961 428962 428963 428964 428965 428966 428967 428968 428969 428970 428971 428972 428973 428974 428975 428976 428977 428978 428979 428980 428981 428982 428983 428984 428985 428986 428987 428988 428989 428990 428991 428992 428993 428994 428995 428996 428997 428998