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GEA Hearing Aid - Indonesia BPOM Medical Device Registration

GEA Hearing Aid is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20702918253. The device is manufactured by XIAMEN NEWSOUND TECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MEGA PRATAMA MEDICALINDO.

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
GEA Hearing Aid
Analysis ID: AKL 20702918253

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. MEGA PRATAMA MEDICALINDO

AR Address

Jl. Pluit Raya 133 Blok A.3

Registration Date

Sep 22, 2022

Expiry Date

Jul 01, 2027

Product Type

Prosthetic Ear, Nose and Throat Equipment

(Deleted) Hearing Aid

Non Radiation Electromedics

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