HEARTMATE 3 Left Ventricular Assist System (LVAS) - Indonesia BPOM Medical Device Registration
HEARTMATE 3 Left Ventricular Assist System (LVAS) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503520009. The device is manufactured by ABBOTT MEDICAL from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. TRANSMEDIC 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 : 3
Manufacturer
ABBOTT MEDICALCountry of Origin
United States
Authorized Representative
PT. TRANSMEDIC INDONESIAAR Address
Perkantoran Menara Era Unit G-01 JL.Senen Raya No.135-137 RT 00 RW 00, Prov. DKI Jakarta, Kota Jakarta Pusat, Kec. Senen, Kel. Senen
Registration Date
Feb 06, 2025
Expiry Date
Sep 23, 2029
Product Type
Prosthetic Cardiology Equipment
Ventricular bypass (assist) device.
Non Radiation Electromedics
QUICKFLEX™ µ Left Heart Lead
ISOFLEX Lead
TACTICATH™ Contact Force Ablation Catheter, Sensor Enabled™
TACTIFLEX ™ Sensor Enabled ™ Ablation Catheter
QUARTET™ Left Heart Lead
TactiSys ™ Quartz Equipment
ELLIPSE™ VR Implantable Cardioverter Defibrillator
ELLIPSE™ DR Implantable Cardioverter Defibrillator
TENDRIL STS Pacing Leads
ELLIPSE VR Implantable Cardioverter Defibrillator
SANYOU Spinal Rod System (Cervical) Implant
SHANGHAI SANYOU MEDICAL CO., LTD.
SANYOU Spinal Rod System (Thoracolumbar) 6
SHANGHAI SANYOU MEDICAL CO., LTD.
SANYOU Spinal Rod System (Cervical) Instrument
SHANGHAI SANYOU MEDICAL CO., LTD.
INGEVITY™+ Lead
BOSTON SCIENTIFIC PUERTO RICO LLC.
INGEVITY™ MRI Lead
BOSTON SCIENTIFIC PUERTO RICO LLC
RELIANCE 4-FRONT™ Active Fixation
BOSTON SCIENTIFIC PUERTO RICO LLC.
STIMULAN KIT
BIOCOMPOSITES LIMITED
STIMULAN RAPID CURE
BIOCOMPOSITES LIMITED
STRYKER Connected OR Hub System
STRYKER ENDOSCOPY
SANYOU Spinal Rod System (Thoracolumbar)
SHANGHAI SANYOU MEDICAL CO., LTD.