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ONEMED Hearing Aid - Indonesia BPOM Medical Device Registration

ONEMED Hearing Aid is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10702028213. The device is manufactured by HUIZHOU JINGHAO ELECTRONICS CO. LTD. from China, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. INTISUMBER HASILSEMPURNA.

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 : A
ONEMED Hearing Aid
Analysis ID: AKL 10702028213

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Country of Origin

China

Authorized Representative

PT. INTISUMBER HASILSEMPURNA

AR Address

KOMPLEK DARMO PARK II BLOK IV NO. 14-15 JL. MAYJEND SUNGKONO SURABAYA

Registration Date

Nov 19, 2020

Expiry Date

Nov 19, 2023

Product Type

Prosthetic Ear, Nose and Throat Equipment

Hearing Aid.

Non Radiation Electromedics

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