Medical Device Division · registration 140155CancelledGambro
Hong KongDialyzers, Hemodialysis, Hollow-FiberClass IVGambro Industries
Official record identity
- MDACS listing number
- 140155
- Model name
- oXiris - Prismaflex Set (112016), oXiris - S Prismaflex Set (955503)
- Registration date
- April 03, 2024
- Source update date
- September 05, 2025
- Status
- Cancelled
Official value: Delisted
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Baxter Healthcare Ltd.
- Manufacturer
- Gambro Industries
Official description
Dialyzers, Hemodialysis, Hollow Fiber
Additional source fields
- AMD nomenclature code
- 11234
- Traditional Chinese local responsible person
- 百特醫療用品有限公司
- Local responsible person phone
- 34053000
- Published manufacturer address
- 7, Avenue Lionel Terray, BP 126, 69883 Meyzieu Cedex, France
- Published remarks
- Delisted.
- Revision number
- d
- Delist date
- 2025-09-05
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.