FUJIFILM SYNAPSE PACS - Indonesia BPOM Medical Device Registration

FUJIFILM SYNAPSE PACS is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21501615443. The device is manufactured by FUJIFILM MEDICAL SYSTEM U.S.A., INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is FUJIFILM INDONESIA.

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BPOM Registered

Risk Class Kelas Resiko : B

FUJIFILM SYNAPSE PACS

Analysis ID: AKL 21501615443

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

FUJIFILM MEDICAL SYSTEM U.S.A., INC.

Country of Origin

United States

Authorized Representative

FUJIFILM INDONESIA

AR Address

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

Registration Date

Apr 05, 2021

Expiry Date

Apr 05, 2026

Product Type

Diagnostic Radiology Equipment

(Dihapus) Picture archiving and communications system.

Non Radiation Electromedics

DJ Fang

MedTech Regulatory Expert

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Other Products from FUJIFILM MEDICAL SYSTEM U.S.A., INC.

Products from the same manufacturer (1 products)

FUJIFILM SYNAPSE VNA

Kelas Resiko : B

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Products with the same authorized representative (10 products)

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FUJI DRI-CHEM NX700 and Accessories

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Kelas Resiko : B

FUJI DRI-CHEM NX600i and Accessories

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Kelas Resiko : B

FUJI DRI-CHEM NX600 and Accessories

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Kelas Resiko : B

FUJI DRI-CHEM SLIDE NH3 – W II

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Kelas Resiko : B

FUJIFILM Digital Mammography System AMULET Sophinity

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Kelas Resiko : C

FUJI DRI-CHEM SLIDE Mg - P III

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Kelas Resiko : B

FUJI DRI-CHEM SLIDE LIP - P

FUJIFILM HEALTHCARE MANUFACTURING CORPORATION MINAMIASHIGARA NAKANUMA OFFICE.

Kelas Resiko : B

FUJI DRI-CHEM Slide HDL-C-PIII D

FUJIFILM HEALTHCARE MANUFACTURING CORPORATION MINAMIASHIGARA NAKANUMA OFFICE.

Kelas Resiko : B