AMPLATZER ™ TorqVue ™ 45 ° x 45 ° Delivery Sheath - Indonesia BPOM Medical Device Registration
AMPLATZER ™ TorqVue ™ 45 ° x 45 ° Delivery Sheath is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501020739. The device is manufactured by ABBOTT MEDICAL from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. NUGRA KARSERA.
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
ABBOTT MEDICALCountry of Origin
United States
Authorized Representative
PT. NUGRA KARSERAAR Address
Rukan Graha Mas Pemuda, Jalan Pemuda Blok AA/ 10
Registration Date
Mar 06, 2020
Expiry Date
Dec 14, 2023
Product Type
Diagnostic Cardiology Equipment
Percutaneous catheter.
Non Electromedic Sterile
HEARTMATE 3 Left Ventricular Assist System (LVAS)
QUARTET™ Left Heart Lead
QUICKFLEX™ µ Left Heart Lead
TACTIFLEX ™ Sensor Enabled ™ Ablation Catheter
ISOFLEX Lead
TACTICATH™ Contact Force Ablation Catheter, Sensor Enabled™
TactiSys ™ Quartz Equipment
ELLIPSE™ VR Implantable Cardioverter Defibrillator
TENDRIL STS Pacing Leads
ELLIPSE™ DR Implantable Cardioverter Defibrillator
TACTIFLEX™ Sensor Enabled™ Ablation Catheter
ABBOTT MEDICAL COSTA RICA LTDA
TACTIFLEX ™ Sensor Enabled ™ Ablation Catheter
ABBOTT MEDICAL
AXS Universal Aspiration Tubing
MEDELA AG
TactiSys ™ Quartz Equipment
ABBOTT MEDICAL
NUGRA Hydrophilic Guide Wire
LEPU MEDICAL TECHNOLOGY (BEIJING) CO,. LTD.
ADVISOR ™ VL Circular Mapping Catheter, Sensor Enabled ™
ABBOTT MEDICAL COSTA RICA LTDA
Z-MED ™ Percutaneous Transluminal Valvulopasty Catheter
NUMED INC.
NUGRA Manifold
LEPU MEDICAL TECHNOLOGY (BEIJING) CO,. LTD.
NUGRA High Pressure Extension Tubing
LEPU MEDICAL TECHNOLOGY (BEIJING) CO,. LTD.
NUGRA Angiographic Catheter
LEPU MEDICAL TECHNOLOGY (BEIJING) CO,. LTD.