SJM™ Pericardial Patch with EnCap ™ Technology - Indonesia BPOM Medical Device Registration
SJM™ Pericardial Patch with EnCap ™ Technology is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503025899. The device is manufactured by GLYCAR S.A.(PTY) LTD from South Africa, 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
GLYCAR S.A.(PTY) LTDCountry of Origin
South Africa
Authorized Representative
PT. TRANSMEDIC INDONESIAAR Address
PERKANTORAN MENARA ERA UNIT G-01, JL. SENEN RAYA NO. 135-137
Registration Date
Oct 07, 2020
Expiry Date
Nov 19, 2023
Product Type
Prosthetic Cardiology Equipment
Replacement heart valve.
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.
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.