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PUREMED Hearing Aid - Indonesia BPOM Medical Device Registration

PUREMED Hearing Aid is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10702121770. The device is manufactured by FOSHAN SHUNDE ALFORD ELECTRONIC CO., LTD. from China, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. ROYAL SEJAHTERA MANDIRI.

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
PUREMED Hearing Aid
Analysis ID: AKL 10702121770

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Country of Origin

China

Authorized Representative

PT. ROYAL SEJAHTERA MANDIRI

AR Address

Ruko Mahkota Ancol Blok E No.53, Jl. RE Martadinata, Kelurahan Pademanagn Barat

Registration Date

Feb 13, 2024

Expiry Date

Feb 12, 2027

Product Type

Prosthetic Ear, Nose and Throat Equipment

(Deleted) Hearing Aid.

Non Radiation Electromedics

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