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GSI Audera AEP/CAEP - Indonesia BPOM Medical Device Registration

GSI Audera AEP/CAEP is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20701714442. The device is manufactured by DIAGNOSTIC GROUP LLC - DBA GRASON-STADLER from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. DEMKA SAKTI.

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.

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BPOM Registered
Risk Class Kelas Resiko : B
GSI Audera AEP/CAEP
Analysis ID: AKL 20701714442

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. DEMKA SAKTI

AR Address

Jl. Tanah Abang III No. 19 A - B, Jakarta Pusat

Registration Date

Jul 09, 2021

Expiry Date

Nov 07, 2025

Product Type

Diagnostic Ear, Nose and Throat Equipment

Audiometer.

Non Radiation Electromedics

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