Medical Device Division · registration 160316Cancelled

Fresenius Medical Care

Name: Fresenius Medical Care — Medical Device Division 160316
Creator: Fresenius Medical Care Japan K.K.
Keywords: Fresenius Medical Care, Fresenius Medical Care, 160316, Dialyzers, Hemodialysis, Hollow-Fiber, Medical Device Division

Hong KongDialyzers, Hemodialysis, Hollow-FiberClass IIIFresenius Medical Care Japan K.K.

Verified

Official record identity

MDACS listing number: 160316
Model name: FX Class High-Flux Dialyser (FX 50 (AP5008851), FX 60 (AP5008861), FX 80 (AP5008881), FX 100 (AP5008901) ), FX Class Middle-Flux Dialysers (FX 60M (AP5004793), FX 80M (AP5004801))
Registration date: August 25, 2016
Source update date: July 15, 2025
Status: Cancelled

Classification

Risk class: Class III
Published category: Dialyzers, Hemodialysis, Hollow-Fiber

Published parties

Registrant / registration holder: Fresenius Medical Care Hong Kong Limited
Manufacturer: Fresenius Medical Care Japan K.K.

Official description

Dialyzers, Hemodialysis, Hollow Fiber

Additional source fields

AMD nomenclature code: 11234
Local responsible person phone: 26068000
Published manufacturer address: 5-13-1, Toranomon, Minato-ku, Tokyo, 105-0001, Japan
Published remarks: Delisted.
Delist date: 2021-07-08

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.