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BIOTRONIK Dynetic-35 Peripheral Balloon Expandable Stent System - HSA Registration DE0506283

Access comprehensive regulatory information for BIOTRONIK Dynetic-35 Peripheral Balloon Expandable Stent System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0506283 and owned by Biotronik AG. The device was registered on October 12, 2021.

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
DE0506283
BIOTRONIK Dynetic-35 Peripheral Balloon Expandable Stent System
HSA Registration Number: DE0506283
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Product Description

The Dynetic-35 is indicated for the treatment of de novo or restenotic atherosclerotic lesions in iliac arteries.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0506283
Registration Date
October 12, 2021
Change Notification Approval Date
May 14, 2025
Retention Due Date
October 11, 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)
Dynetic-35 5/18/90 Dynetic-35 6/18/90 Dynetic-35 7/18/90 Dynetic-35 5/28/90 Dynetic-35 6/28/90 Dynetic-35 7/28/90 Dynetic-35 5/38/90 Dynetic-35 6/38/90 Dynetic-35 7/38/90 Dynetic-35 5/58/90 Dynetic-35 6/58/90 Dynetic-35 7/58/90 Dynetic-35 7/78/90 Dynetic-35 5/18/130 Dynetic-35 6/18/130 Dynetic-35 7/18/130 Dynetic-35 5/28/130 Dynetic-35 6/28/130 Dynetic-35 7/28/130 Dynetic-35 5/38/130 Dynetic-35 6/38/130 Dynetic-35 7/38/130 Dynetic-35 5/58/130 Dynetic-35 6/58/130 Dynetic-35 7/58/130 Dynetic-35 7/78/130 Dynetic-35 5/18/170 Dynetic-35 6/18/170 Dynetic-35 7/18/170 Dynetic-35 5/28/170 Dynetic-35 6/28/170 Dynetic-35 7/28/170 Dynetic-35 5/38/170 Dynetic-35 6/38/170 Dynetic-35 7/38/170 Dynetic-35 5/58/170 Dynetic-35 6/58/170 Dynetic-35 7/58/170 Dynetic-35 7/78/170 Dynetic-35 8/18/90 Dynetic-35 8/28/90 Dynetic-35 9/28/90 Dynetic-35 10/28/90 Dynetic-35 8/38/90 Dynetic-35 9/38/90 Dynetic-35 10/38/90 Dynetic-35 8/58/90 Dynetic-35 9/58/90 Dynetic-35 10/58/90 Dynetic-35 8/78/90 Dynetic-35 9/78/90 Dynetic-35 10/78/90 Dynetic-35 8/18/130 Dynetic-35 8/28/130 Dynetic-35 9/28/130 Dynetic-35 10/28/130 Dynetic-35 8/38/130 Dynetic-35 9/38/130 Dynetic-35 10/38/130 Dynetic-35 8/58/130 Dynetic-35 9/58/130 Dynetic-35 10/58/130 Dynetic-35 8/78/130 Dynetic-35 9/78/130 Dynetic-35 10/78/130 Dynetic-35 8/18/170 Dynetic-35 8/28/170 Dynetic-35 9/28/170 Dynetic-35 10/28/170 Dynetic-35 8/38/170 Dynetic-35 9/38/170 Dynetic-35 10/38/170 Dynetic-35 8/58/170 Dynetic-35 9/58/170 Dynetic-35 10/58/170 Dynetic-35 8/78/170 Dynetic-35 9/78/170 Dynetic-35 10/78/170
Model Identifier(s)
428690 428691 428692 428694 428695 428696 428700 428701 428702 428706 428707 428708 428712 428716 428717 428718 428720 428721 428722 428726 428727 428728 428732 428733 428734 428738 428742 428743 428744 428746 428747 428748 428752 428753 428754 428758 428759 428760 428764 448939 448942 448943 448944 448945 448946 448947 448948 448949 448950 448951 448952 448953 448954 448957 448958 448959 448960 448961 448962 448963 448964 448965 448966 448967 448968 448969 448972 448973 448974 448975 448976 448977 448978 448979 448980 448981 448982 448983