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ReSound KE188-DWH - Indonesia BPOM Medical Device Registration

ReSound KE188-DWH is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20702320124. The device is manufactured by GN RESOUND A/S from Denmark, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is HEARING AIDS 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.

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Risk Class Kelas Resiko : B
ReSound KE188-DWH
Analysis ID: AKL 20702320124

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

GN RESOUND A/S

Country of Origin

Denmark

Authorized Representative

HEARING AIDS INDONESIA

AR Address

Sentra Salemba Mas Kav. A Jl. Salemba Raya No. 34-36 Kenari, Senen, Jakarta Pusat

Registration Date

May 12, 2023

Expiry Date

Oct 21, 2025

Product Type

Prosthetic Ear, Nose and Throat Equipment

(Deleted) Hearing Aid

Non Radiation Electromedics

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