Medical Device Division · registration 110061CancelledGambro
Hong KongDialysate, HemodialysisClass IIIGambro Lundia AB
Official record identity
- MDACS listing number
- 110061
- Model name
- BiCart (650/720, 1150/1250)
- Registration date
- January 19, 2022
- Source update date
- September 08, 2025
- Status
- Cancelled
Official value: Delisted
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Baxter Healthcare Ltd.
- Manufacturer
- Gambro Lundia AB
Official description
Dialysate, Hemodialysis
Additional source fields
- AMD nomenclature code
- 16641
- Traditional Chinese local responsible person
- 百特醫療用品有限公司
- Local responsible person phone
- 34053000
- Published manufacturer address
- Box 10101, Magistratsvagen 16, SE-220 10 Lund, Sweden
- 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.