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ONEHEALTH HEARING AID - Indonesia BPOM Medical Device Registration

ONEHEALTH HEARING AID is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10702320137. The device is manufactured by ZHONGSHAN XIAOLAN TOWN SENLAN ELECTRONIC FACTORY from China, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. MEDICAL ERA ALKESINDO.

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
ONEHEALTH HEARING AID
Analysis ID: AKL 10702320137

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Country of Origin

China

Authorized Representative

PT. MEDICAL ERA ALKESINDO

AR Address

Jl. Sisingamangaraja Kilometer 10.8, Komplek Amplas Trade Centre Blok Mahoni nomor 08, Kota Medan, Provinsi Sumatera Utara, Kode Pos: 20148

Registration Date

Jun 16, 2023

Expiry Date

Jun 13, 2026

Product Type

Prosthetic Ear, Nose and Throat Equipment

Air-conduction hearing aid.

Non Radiation Electromedics

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