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Biotronik Oscar Peripheral Multifunctional Catheter System - HSA Registration DE0508241

Access comprehensive regulatory information for Biotronik Oscar Peripheral Multifunctional Catheter System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508241 and owned by Biotronik AG. The device was registered on June 26, 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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CLASS B
DE0508241
Biotronik Oscar Peripheral Multifunctional Catheter System
HSA Registration Number: DE0508241
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Product Description

Oscar is indicated for percutaneous transluminal interventions in the peripheral vasculature to provide support during access into and to dilate stenoses in femoral, popliteal and infrapopliteal arteries. The product is also intended for injection of radiopaque contrast media for the purpose of angiography.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0508241
Registration Date
June 26, 2023
Retention Due Date
June 25, 2025
Product Owner
Short Name
Biotronik
Address
Ackerstrasse 6, 8180 Bรผlach, SWITZERLAND
Registrant
Address
165 KALLANG WAY, #07-00, SINGAPORE 349257
Importer
Address
165 KALLANG WAY, #07-00, SINGAPORE 349257
Model Information
Model Name(s)
Oscar Peripheral Multifunctional Catheter Oscar Peripheral Multifunctional Catheter Oscar Peripheral Multifunctional Catheter Oscar Peripheral Multifunctional Catheter Oscar Peripheral Multifunctional Catheter Oscar Peripheral Multifunctional Catheter Oscar Peripheral Multifunctional Catheter Oscar Peripheral Multifunctional Catheter Oscar Peripheral Multifunctional Catheter Oscar Peripheral Multifunctional Catheter Oscar Peripheral Multifunctional Catheter Oscar PTA Balloon Oscar PTA Balloon Oscar PTA Balloon Oscar PTA Balloon Oscar PTA Balloon Oscar PTA Balloon Oscar PTA Balloon Oscar PTA Balloon Oscar PTA Balloon Oscar PTA Balloon Oscar PTA Balloon
Model Identifier(s)
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