SJM Tailor Annuloplasty Ring - Indonesia BPOM Medical Device Registration
SJM Tailor Annuloplasty Ring is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20503714814. 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. 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 : 2
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 19, 2024
Expiry Date
Feb 14, 2028
Product Type
Prosthetic Cardiology Equipment
Annuloplasty ring (dihapus)
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
SANYOU Spinal Rod System (Cervical) Implant
SHANGHAI SANYOU MEDICAL CO., LTD.
HEARTMATE 3 Left Ventricular Assist System (LVAS)
ABBOTT MEDICAL
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
SANYOU Spinal Rod System (Thoracolumbar)
SHANGHAI SANYOU MEDICAL CO., LTD.

