ROTAPRO™ Advancer Burr Advancing Device - Indonesia BPOM Medical Device Registration
ROTAPRO™ Advancer Burr Advancing Device is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20504220003. The device is manufactured by BOSTON SCIENTIFIC LIMITED from Ireland, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is BOSTON SCIENTIFIC INDONESIA.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 2
Manufacturer
BOSTON SCIENTIFIC LIMITEDCountry of Origin
Ireland
Authorized Representative
BOSTON SCIENTIFIC INDONESIAAR Address
Prudential Tower lantai 28 Jl. Jend. Sudirman Kav. 79
Registration Date
Jan 12, 2022
Expiry Date
Jan 26, 2026
Product Type
Surgical Cardiology Equipment
Coronary atherectomy catheter
Non Electromedic Sterile
EXTRACTOR PRO Retrieval Ballon Catheter
WALLFLEX Esophageal Partially Covered Stent System
WALLFLEX Esophageal Stent System, Fully Covered
WOLVERINE Coronary Cutting Balloon Monorail Microsurgical Dilatation Device
ESSENTIO™ MRI EL DR Pacemaker
ESSENTIO MRI SR Pacemaker
ESSENTIO™ MRI DR Pacemaker
SYNERGY SHIELD MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System
WATCHMAN TruSeal Access System
VORTX Diamond – 18 Fibered Platinum Coil
AngioJet AVX Over-The-Wire Thrombectomy Set
BOSTON SCIENTIFIC CORPORATION, DORADO
FARADRIVE Steerable Sheath
CENTERPOINT SYSTEMS, LLC., UTAH
IMAGER II Urology Torque Catheter
TELEFLEX MEDICAL DE MEXICO, S. DE R.L. DE C.V.
FARASTAR Pulsed Field Ablation Generator and Components
BOSTON SCIENTIFIC CORPORATION, ST. PAUL
OptiCross 35 15MHz Peripheral Imaging Catheter
BOSTON SCIENTIFIC CORPORATION, EL COYOL
IMAGER II Angiographic Catheter
TELEFLEX MEDICAL DE MEXICO, S. DE R.L. DE C.V., NUEVO LAREDO - MEXICO
SYNERGY SHIELD MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC LIMITED
Rotablator™ Rotational Atherectomy System
BOSTON SCIENTIFIC CORPORATION
EXPECT Flexible Endoscopic Ultrasound Aspiration Needle
BOSTON SCIENTIFIC CORPORATION
VORTX Diamond – 18 Fibered Platinum Coil
BOSTON SCIENTIFIC LIMITED