SWIDE Drug Coated Coronary Balloon Catheter - Indonesia BPOM Medical Device Registration
SWIDE Drug Coated Coronary Balloon Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30505128090. The device is manufactured by SHANGHAI SHENQI MEDICAL TECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is TRITRA PRIMA 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
SHANGHAI SHENQI MEDICAL TECHNOLOGY CO., LTD.Country of Origin
China
Authorized Representative
TRITRA PRIMA INDONESIAAR Address
Taman Sari Persada Blok F-1 Nomor 10
Registration Date
Dec 23, 2021
Expiry Date
Aug 05, 2026
Product Type
Therapeutic Cardiology Equipment
(Tidak digunakan) Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (double)
Non Electromedic Sterile
VEDKANG Disposable Non-electric Biopsy Forceps
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
VEDKANG Disposable Endoscopic Hemoclips
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
VEDKANG Disposable Polyp Snares
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
VEDKANG Injection Needles
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
VEDKANG Non-vascular Guidewires
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
ISL100 Pro Intravascular Lithotripsy Generator
SONOSEMI MEDICAL CO., LTD.
LiqMagic C14 Coronary Intravascular Lithotripsy Catheter
SONOSEMI MEDICAL CO., LTD.
ArcBlate Focused Ultrasound Ablation System
EPISONICA CORPORATION
AUGMENTO Automated Radiological Image Processing Software
DEEPTEK MEDICAL IMAGING PRIVATE LIMITED
OvaCis Rapid Test
MP BIOMEDICALS ASIA PACIFIC PTE., LTD.