Medical Device Division · registration 120083Active

Fresenius Medical Care

Name: Fresenius Medical Care — Medical Device Division 120083
Creator: Fresenius Medical Care AG & Co. KGaA
Keywords: Fresenius Medical Care, Fresenius Medical Care, 120083, Peritoneal Dialysis Unit Tubing Sets, Medical Device Division

Hong KongPeritoneal Dialysis Unit Tubing SetsClass IIFresenius Medical Care AG & Co. KGaA

Verified

Official record identity

MDACS listing number: 120083
Model name: Sleep.Safe Set Paed (5017391), Sleep Safe Set Plus (5016931), Sleep.Safe Sample Bag (5055081), Safe Lock PD-Night Drain Line Extension (5014611), Safe Lock PD-Night Drainage-Set (5019571), Sleep Safe Luer-Lock Adaptor (5016971), PIN reload (5017001)
Registration date: January 18, 2022
Expiry date: April 02, 2027
Source update date: April 11, 2025
Status: Active

Classification

Risk class: Class II
Published category: Peritoneal Dialysis Unit Tubing Sets

Published parties

Registrant / registration holder: Fresenius Medical Care Hong Kong Limited
Manufacturer: Fresenius Medical Care AG & Co. KGaA

Official description

Peritoneal Dialysis Unit Tubing Sets

Additional source fields

AMD nomenclature code: 11227
Local responsible person phone: 26068000
Published manufacturer address: 61346 Bad Homburg, GERMANY
Revision number: c

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.