Singapore HSA registration DE0505711

BIOTRONIK ORSIRO MISSION SIROLIMUS ELUTING CORONARY STENT SYSTEM

Singapore·CLASS COM·Biotronik AG·Registered April 26, 2021

Device classification

Device Class: CLASS COM
Medical Speciality Area: Cardiovascular

Registration information

Registration Number: DE0505711
Registration Date: April 26, 2021
Change Notification Approval Date: October 04, 2024
Retention Due Date: April 25, 2026

Product description

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 ≤ 40mm) 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): Orsiro Mission 2.25/9 Orsiro Mission 2.5/9 Orsiro Mission 2.75/9 Orsiro Mission 3.0/9 Orsiro Mission 3.5/9 Orsiro Mission 4.0/9 Orsiro Mission 2.25/13 Orsiro Mission 2.5/13 Orsiro Mission 2.75/13 Orsiro Mission 3.0/13 Orsiro Mission 3.5/13 Orsiro Mission 4.0/13 Orsiro Mission 2.25/15 Orsiro Mission 2.5/15 Orsiro Mission 2.75/15 Orsiro Mission 3.0/15 Orsiro Mission 3.5/15 Orsiro Mission 4.0/15 Orsiro Mission 2.25/18 Orsiro Mission 2.5/18 Orsiro Mission 2.75/18 Orsiro Mission 3.0/18 Orsiro Mission 3.5/18 Orsiro Mission 4.0/18 Orsiro Mission 2.25/22 Orsiro Mission 2.5/22 Orsiro Mission 2.75/22 Orsiro Mission 3.0/22 Orsiro Mission 3.5/22 Orsiro Mission 4.0/22 Orsiro Mission 2.25/26 Orsiro Mission 2.5/26 Orsiro Mission 2.75/26 Orsiro Mission 3.0/26 Orsiro Mission 3.5/26 Orsiro Mission 4.0/26 Orsiro Mission 2.25/30 Orsiro Mission 2.5/30 Orsiro Mission 2.75/30 Orsiro Mission 3.0/30 Orsiro Mission 3.5/30 Orsiro Mission 4.0/30 Orsiro Mission 2.25/35 Orsiro Mission 2.5/35 Orsiro Mission 2.75/35 Orsiro Mission 3.0/35 Orsiro Mission 3.5/35 Orsiro Mission 4.0/35 Orsiro Mission 2.25/40 Orsiro Mission 2.5/40 Orsiro Mission 2.75/40 Orsiro Mission 3.0/40 Orsiro Mission 3.5/40 Orsiro Mission 4.0/40 Orsiro Mission 4.0/40
Model Identifier(s): 419101 419102 419103 419104 419105 419106 419107 419108 419109 419110 419111 419112 419113 419114 419115 419116 419117 419118 419119 419120 419121 419122 419123 419124 419125 419126 419127 419128 419129 419130 419131 419132 419133 419134 419135 419136 419137 419138 419139 419140 419141 419142 419143 419144 419145 419146 419147 419148 419149 419150 419151 419152 419153 419154 419154

About this record

Access comprehensive regulatory information for BIOTRONIK ORSIRO MISSION 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 DE0505711 and owned by Biotronik AG. The device was registered on April 26, 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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