Medical Device Division · registration 241035Active

AMULET SOPHINITY (FDR MS-4000), AMULET ELITE (FDR MS-4000)

Name: AMULET SOPHINITY (FDR MS-4000), AMULET ELITE (FDR MS-4000) — Medical Device Division 241035
Creator: FUJIFILM Corporation
Keywords: AMULET SOPHINITY (FDR MS-4000), AMULET ELITE (FDR MS-4000), AMULET SOPHINITY (FDR MS-4000), AMULET ELITE (FDR MS-4000), 241035, Radiographic Systems, Digital, Mammographic, Medical Device Division

Hong KongRadiographic Systems, Digital, MammographicClass IIIFUJIFILM Corporation

Verified

Official record identity

MDACS listing number: 241035
Model name: AMULET SOPHINITY (FDR MS-4000), AMULET ELITE (FDR MS-4000)
Registration date: January 07, 2026
Expiry date: September 08, 2029
Source update date: January 08, 2026
Status: Active

Classification

Risk class: Class III
Published category: Radiographic Systems, Digital, Mammographic

Published parties

Registrant / registration holder: FUJIFILM Hong Kong Limited
Manufacturer: FUJIFILM Corporation

Official description

Radiographic Systems, Digital, Mammographic

Additional source fields

AMD nomenclature code: 18432
Traditional Chinese local responsible person: 富士膠片香港有限公司
Local responsible person phone: 23760998
Published manufacturer address: 26-30, Nishiazabu 2-Chome, Minato-Ku, Tokyo, 106-8620 JAPAN
Revision number: a

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.