Medical Device Division · registration 180138Active

Respironics

Name: Respironics — Medical Device Division 180138
Creator: Respironics, Inc.
Keywords: Respironics, Respironics, 180138, Positive Airway Pressure Units, Bi-Level, Medical Device Division

Hong KongPositive Airway Pressure Units, Bi-LevelClass IIIRespironics, Inc.

Verified

Official record identity

MDACS listing number: 180138
Model name: DreamStation BiPAP ST (INX1025S19, INX1025H19, INX1025T19, INX1030S19, INX1030H19, INX1030T19), DreamStation BiPAP AVAPS (INX1125S19, INX1125H19, INX1125T19, INX1130S19, INX1130H19, INX1130T19, INX1131S19, INX1131H19, INX1131T19)
Registration date: May 12, 2023
Expiry date: May 12, 2028
Source update date: March 06, 2025
Status: Active

Classification

Risk class: Class III
Published category: Positive Airway Pressure Units, Bi-Level

Published parties

Registrant / registration holder: Philips Electronics Hong Kong Limited
Manufacturer: Respironics, Inc.

Official description

Positive Airway Pressure Units, Bi-Level

Additional source fields

AMD nomenclature code: 20743
Traditional Chinese local responsible person: 飛利浦電子香港有限公司
Local responsible person phone: 28215888
Published manufacturer address: 1001 Murry Ridge Lane, Murrysville PA 15668, USA
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.