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Singapore HSA registration DE0508241

Biotronik Oscar Peripheral Multifunctional Catheter System

Singapore flagSingapore·CLASS B·Biotronik AG·Registered June 26, 2023
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 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.
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)
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)
454332 454333 454334 454335 454336 454337 454338 454339 454340 454341 454342 454343 454344 454345 454346 454347 454348 454349 454350 454351 454352 454353
About this record

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B