Singapore HSA registration DE0508516

BIOTRONIK Synsiro Pro Sirolimus Eluting Coronary Stent System

Singapore·CLASS COM·Biotronik AG·Registered September 25, 2023

Device classification

Device Class: CLASS COM
Medical Speciality Area: Cardiovascular

Registration information

Registration Number: DE0508516
Registration Date: September 25, 2023
Change Notification Approval Date: October 03, 2024
Retention Due Date: September 24, 2025

Product description

Synsiro Pro stent is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de-novo stenotic lesions and in-stent restenotic lesions (length ≤ 40 mm) in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm including the following patient and lesion subsets: •Acute Coronary Syndrome (ACS) •ST-Elevation Myocardial Infarction (STEMI) •Diabetes Mellitus (DM) •Complex Lesions (B2/C) •High Bleeding Risk (HBR) •Long Lesions (LL) (e.g. ≥ 20 mm) •Small Vessels (SV) (e.g. ≤ 2.75 mm) •Multi-Vessel Disease (MVD) •Male/Female •Old Patients (e.g. > 65 y).

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): Synsiro Pro 2.25/9 Synsiro Pro 2.5/9 Synsiro Pro 2.75/9 Synsiro Pro 3.0/9 Synsiro Pro 3.5/9 Synsiro Pro 4.0/9 Synsiro Pro 2.25/13 Synsiro Pro 2.5/13 Synsiro Pro 2.75/13 Synsiro Pro 3.0/13 Synsiro Pro 3.5/13 Synsiro Pro 4.0/13 Synsiro Pro 2.25/15 Synsiro Pro 2.5/15 Synsiro Pro 2.75/15 Synsiro Pro 3.0/15 Synsiro Pro 3.5/15 Synsiro Pro 4.0/15 Synsiro Pro 2.25/18 Synsiro Pro 2.5/18 Synsiro Pro 2.75/18 Synsiro Pro 3.0/18 Synsiro Pro 3.5/18 Synsiro Pro 4.0/18 Synsiro Pro 2.25/22 Synsiro Pro 2.5/22 Synsiro Pro 2.75/22 Synsiro Pro 3.0/22 Synsiro Pro 3.5/22 Synsiro Pro 4.0/22 Synsiro Pro 2.25/26 Synsiro Pro 2.5/26 Synsiro Pro 2.75/26 Synsiro Pro 3.0/26 Synsiro Pro 3.5/26 Synsiro Pro 4.0/26 Synsiro Pro 2.25/30 Synsiro Pro 2.5/30 Synsiro Pro 2.75/30 Synsiro Pro 3.0/30 Synsiro Pro 3.5/30 Synsiro Pro 4.0/30 Synsiro Pro 2.25/35 Synsiro Pro 2.5/35 Synsiro Pro 2.75/35 Synsiro Pro 3.0/35 Synsiro Pro 3.5/35 Synsiro Pro 4.0/35 Synsiro Pro 2.25/40 Synsiro Pro 2.5/40 Synsiro Pro 2.75/40 Synsiro Pro 3.0/40 Synsiro Pro 3.5/40 Synsiro Pro 4.0/40
Model Identifier(s): 419155 419156 419157 419158 419159 419160 419161 419162 419163 419164 419165 419166 419167 419168 419169 419170 419171 419172 419173 419174 419175 419176 419177 419178 419179 419180 419181 419182 419183 419184 419185 419186 419187 419188 419189 419190 419191 419192 419193 419194 419195 419196 419197 419198 419199 419200 419201 419202 419203 419204 419205 419206 419207 419208

About this record

Access comprehensive regulatory information for BIOTRONIK Synsiro Pro Sirolimus Eluting Coronary Stent 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 DE0508516 and owned by Biotronik AG. The device was registered on September 25, 2023.

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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