ArcBlate Focused Ultrasound Ablation System - Indonesia BPOM Medical Device Registration
ArcBlate Focused Ultrasound Ablation System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21502420033. The device is manufactured by EPISONICA CORPORATION from Taiwan (China), and is classified as Risk Class Kelas Resiko : C. 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 : 2
Manufacturer
EPISONICA CORPORATIONCountry of Origin
Taiwan (China)
Authorized Representative
TRITRA PRIMA INDONESIAAR Address
Central Park Cikarang Blok A1 No. 02
Registration Date
Aug 26, 2024
Expiry Date
May 08, 2029
Product Type
Therapeutic Radiology Equipment
High Intensity Focused Ultrasound
Non Radiation Electromedics
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