GUSTA PTCA Balloon Dilatation Catheter - Indonesia BPOM Medical Device Registration
GUSTA PTCA Balloon Dilatation Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20505320323. The device is manufactured by BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MEDITRANS GLOBAL.
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
BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.Country of Origin
China
Authorized Representative
PT. MEDITRANS GLOBALAR Address
Jl. Rungkut Menanggal Harapan Blok O no. 28 Surabaya 60293
Registration Date
Dec 02, 2023
Expiry Date
Jan 03, 2025
Product Type
Therapeutic Cardiology Equipment
Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
Non Electromedic Sterile
GUSTA NC Balloon Dilatation Catheter
GUSTA II NC PTCA Balloon Dilatation Catheter
DEMAX Introducer Sheath Kit
DEMAX Push - Click Y Connector Kit
DEMAX Manifolds
DEMAX Balloon In-Deflation Device
DEMAX Interventional Device Set
EVERFLOW Paclitaxel-coated Coronary Balloon Catheter
DONGGUAN TT MEDICAL, INC.
Cornaris P80-E Multimodality Intravascular Imaging System
SHENZHEN VIVOLIGHT MEDICAL DEVICE & TECHNOLOGY CO., LTD.
CORNARIS Pathfinder 164 Disposable Intravascular Imaging Catheter
SHENZHEN VIVOLIGHT MEDICAL DEVICE & TECHNOLOGY CO., LTD.
MIRAII Pressure Bandage
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD
LTV2 Series Ventilator
VYAIRE MEDICAL INC.
MIRAII Extension Tube
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
GUSTA NC Balloon Dilatation Catheter
BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.
MIRAII Introducer Set
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
GUSTA II NC PTCA Balloon Dilatation Catheter
BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.
MIRAII Angiographic Catheter
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.