BiopSee - Indonesia BPOM Medical Device Registration

BiopSee is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21501321206. The device is manufactured by MEDCOM GESELLSCHAFT FÜR MEDIZINISCHE BILDVERARBEITUNG MBH from Germany, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is FUJIFILM INDONESIA.

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BPOM Registered

Risk Class Kelas Resiko : C

BiopSee

Analysis ID: AKL 21501321206

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

MEDCOM GESELLSCHAFT FÜR MEDIZINISCHE BILDVERARBEITUNG MBH

Country of Origin

Germany

Authorized Representative

FUJIFILM INDONESIA

AR Address

: EightyEight@Kasablanka Office Tower A, Lantai 36 Jl. Casablanca Raya Kav. 88, Desa/Kelurahan Menteng Dalam, Kec. Tebet, Kota Adm. Jakarta Selatan, Provinsi DKI Jakarta, Kode Pos: 12870 No Telp: 021-21282182

Registration Date

Aug 19, 2023

Expiry Date

Jun 30, 2026

Product Type

Diagnostic Radiology Equipment

Medical image management and processing system.

Non Radiation Electromedics

DJ Fang

MedTech Regulatory Expert

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Kelas Resiko : B

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