GSI Audera Pro - Indonesia BPOM Medical Device Registration
GSI Audera Pro is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20701026745. The device is manufactured by INTELLIGENT HEARING SYSTEMS from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is DEMKA SAKTI.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
INTELLIGENT HEARING SYSTEMSCountry of Origin
United States
Authorized Representative
DEMKA SAKTIAR Address
Jl. Tanah Abang III No. 19 A - B, Jakarta Pusat
Registration Date
Nov 09, 2020
Expiry Date
Nov 07, 2025
Product Type
Diagnostic Ear, Nose and Throat Equipment
Audiometer.
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