ESTONIAN 1 - Indonesia BPOM Medical Device Registration
ESTONIAN 1 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20702128012. The device is manufactured by BERNAFON AT from Switzerland, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. 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.
VIRON 1
Risk Classification
Product Class
Kelas : 2
Manufacturer
BERNAFON ATCountry of Origin
Switzerland
Authorized Representative
PT. HEARING AIDS INDONESIAAR Address
Sentra Salemba Mas Kav. A Jl. Salemba Raya No. 34-36 Kenari, Senen, Jakarta Pusat
Registration Date
Dec 17, 2021
Expiry Date
Feb 01, 2025
Product Type
Prosthetic Ear, Nose and Throat Equipment
(Deleted) Hearing Aid
Non Radiation Electromedics
ESTONIAN 1
SBO HEARING A/S
BERNAFON Viron 3
SBO HEARING A/S
BERNAFON Viron 1
SBO HEARING A/S
BERNAFON LX 3
SBO HEARING A/S
BERNAFON LX 7
SBO HEARING A/S
ReSound KE177-DW
GN RESOUND A/S
ABDI Hearing Aid
HUIZHOU JINGHAO MEDICAL TECHNOLOGY CO., LTD.
JINGHAO Hearing Aid
HUIZHOU JINGHAO MEDICAL TECHNOLOGY CO., LTD.
ESTONIAN 5
DGS POLAND SP. Z.O.O
ESTONIAN 3
BERNAFON AT