REVOLUTION 45 MHz Rotational Imaging Catheter - Indonesia BPOM Medical Device Registration
REVOLUTION 45 MHz Rotational Imaging Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21501716782. The device is manufactured by VOLCANO CORPORATION BY VOLCARICA S.R.L. from Costa Rica, and is classified as Risk Class Kelas Resiko : B. 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
VOLCANO CORPORATION BY VOLCARICA S.R.L.Country of Origin
Costa Rica
Authorized Representative
PT. TRANSMEDIC INDONESIAAR Address
Perkantoran Menara Era Unit G-01 & G-02 Jl. Senen Raya No 135-137, Kel. Senen Kec. Senen, Jakarta Pusat 10410
Registration Date
Apr 22, 2019
Expiry Date
Dec 31, 2023
Product Type
Diagnostic Radiology Equipment
Diagnostic ultrasonic transducer.
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.
INGEVITYโข+ Lead
BOSTON SCIENTIFIC PUERTO RICO LLC.
INGEVITYโข MRI Lead
BOSTON SCIENTIFIC PUERTO RICO LLC
RELIANCE 4-FRONTโข 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.

