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Singapore HSA registration DE0018256

Biotronik Dynamic Renal Stent System

Singapore flagSingapore·CLASS C·Biotronik AG·Registered June 17, 2016
Device classification
Device Class
CLASS C
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0018256
Registration Date
June 17, 2016
Change Notification Approval Date
October 31, 2023
Retention Due Date
June 16, 2025
Product description
The Dynamic Renal Stent System is indicated for improving arterial luminal diameter in patients with clinical symptoms attributable to atherosclerotic stenosis of the renal arteries.
Product Owner
Name
Biotronik AG
Short Name
Biotronik
Address
Ackerstrasse 6, 8180 Bülach, SWITZERLAND
Registrant
Name
BIOTRONIK ASIA PACIFIC PTE. LTD.
Address
165 KALLANG WAY, #07-00, SINGAPORE 349257
Importer
Name
BIOTRONIK ASIA PACIFIC PTE. LTD.
Address
165 KALLANG WAY, #07-00, SINGAPORE 349257
Model information
Model Name(s)
Dynamic Renal Stent System 4.5/12/80 Dynamic Renal Stent System 5.0/12/80 Dynamic Renal Stent System 6.0/12/80 Dynamic Renal Stent System 7.0/12/80 Dynamic Renal Stent System 4.5/19/80 Dynamic Renal Stent System 5.0/19/80 Dynamic Renal Stent System 6.0/19/80 Dynamic Renal Stent System 7.0/19/80 Dynamic Renal Stent System 4.5/12/140 Dynamic Renal Stent System 5.0/12/140 Dynamic Renal Stent System 6.0/12/140 Dynamic Renal Stent System 7.0/12/140 Dynamic Renal Stent System 4.5/19/140 Dynamic Renal Stent System 5.0/19/140 Dynamic Renal Stent System 6.0/19/140 Dynamic Renal Stent System 7.0/19/140 Dynamic Renal Stent System 4.5/15/80 Dynamic Renal Stent System 5.0/15/80 Dynamic Renal Stent System 6.0/15/80 Dynamic Renal Stent System 7.0/15/80 Dynamic Renal Stent System 4.5/15/140 Dynamic Renal Stent System 5.0/15/140 Dynamic Renal Stent System 6.0/15/140 Dynamic Renal Stent System 7.0/15/140
Model Identifier(s)
358574 358575 358576 358577 358578 358579 358580 358581 358582 358583 358584 358585 358586 358587 358588 358589 368707 368708 368709 368710 368711 368712 368713 368714
About this record

Access comprehensive regulatory information for Biotronik Dynamic Renal Stent System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0018256 and owned by Biotronik AG. The device was registered on June 17, 2016.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C