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FUJIFILM Digital Mammography System AMULET Innovality - Indonesia BPOM Medical Device Registration

FUJIFILM Digital Mammography System AMULET Innovality is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21501813884. The device is manufactured by FUJIFILM HEALTHCARE MANUFACTURING CORPORATION HANAMAKI OFFICE from Japan, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. FUJIFILM INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : C
FUJIFILM Digital Mammography System AMULET Innovality
Analysis ID: AKL 21501813884

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Japan

Authorized Representative

PT. FUJIFILM INDONESIA

AR Address

Eightyeight@Kasablanka Office Tower Lantai 36, Unit A, B dan C, Jl. Casablanca Kav. 88

Registration Date

Dec 30, 2022

Expiry Date

Jun 30, 2026

Product Type

Diagnostic Radiology Equipment

Mammographic x-ray system.

Electromedic Radiation

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