INGEVITY™ MRI Lead - Indonesia BPOM Medical Device Registration
INGEVITY™ MRI Lead is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503220145. The device is manufactured by BOSTON SCIENTIFIC PUERTO RICO LLC from Puerto Rico USA, 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
BOSTON SCIENTIFIC PUERTO RICO LLCCountry of Origin
Puerto Rico USA
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
Jan 13, 2025
Expiry Date
Aug 01, 2027
Product Type
Prosthetic Cardiology Equipment
Implantable pacemaker pulse generator.
Non Electromedic Sterile
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.
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.