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Singapore HSA registration DE0502058

Biotronik Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System

Singapore flagSingapore·CLASS COM·Biotronik AG·Registered August 27, 2018
Device classification
Device Class
CLASS COM
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0502058
Registration Date
August 27, 2018
Change Notification Approval Date
October 31, 2023
Retention Due Date
August 26, 2025
Product description
is indicated for improving luminal diameter in the treatment of de novo native coronary artery lesions in patients with symptomatic coronary artery disease. The reference vessel diameter should closely match the scaffold nominal diameter. The treated lesion length should be less than the nominal scaffold length.
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)
Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium System Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium System Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium System Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium System Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium System Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium System
Model Identifier(s)
412526 412527 412528 412529 412530 412531
About this record

Access comprehensive regulatory information for Biotronik Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System in the Singapore medical device market through Pure Global AI's free database. This CLASS COM medical device is registered under HSA registration number DE0502058 and owned by Biotronik AG. The device was registered on August 27, 2018.

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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