NATUS ALGO 3i Newborn Hearing Screener - Indonesia BPOM Medical Device Registration

NATUS ALGO 3i Newborn Hearing Screener is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20701614029. The device is manufactured by CREATION TECHNOLOGIES LP. from Canada, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. IDS MEDICAL SYSTEMS INDONESIA.

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BPOM Registered

Risk Class Kelas Resiko : B

NATUS ALGO 3i Newborn Hearing Screener

Analysis ID: AKL 20701614029

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

CREATION TECHNOLOGIES LP.

Country of Origin

Canada

Authorized Representative

PT. IDS MEDICAL SYSTEMS INDONESIA

AR Address

Gedung Wisma 76, Lantai 17 & 22, Jl. LetJend. S. Parman Kav.76, Kelurahan Slipi, Kecamatan Palmerah, 11410

Registration Date

Dec 15, 2023

Expiry Date

Nov 30, 2026

Product Type

Diagnostic Ear, Nose and Throat Equipment

Auditory impedance tester.

Non Radiation Electromedics

DJ Fang

MedTech Regulatory Expert

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