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OTODYNAMICS OTOPORT OAE + ABR System - Indonesia BPOM Medical Device Registration

OTODYNAMICS OTOPORT OAE + ABR System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20701814726. The device is manufactured by OTODYNAMICS LTD. from United Kingdom, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. HEARING VISION.

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BPOM Registered
Risk Class Kelas Resiko : B
OTODYNAMICS OTOPORT OAE + ABR System
Analysis ID: AKL 20701814726

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

OTODYNAMICS LTD.

Country of Origin

United Kingdom

Authorized Representative

PT. HEARING VISION

AR Address

Darmawangsa Square Lantai 3 No.52 Jl. Darmawangsa VI & IX, Kelurahan Pulo Kecamatan Kebayoran Baru Jakarta Selatan

Registration Date

Sep 22, 2022

Expiry Date

Apr 11, 2025

Product Type

Diagnostic Ear, Nose and Throat Equipment

Audiometer.

Non Radiation Electromedics

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