180138
III
current
Positive Airway Pressure Units, Bi-Levelๆฐ้ๆญฃๅ้ๆฐ่ฃ ็ฝฎ,ๅๆฐดๅนณ
This profile provides complete Hong Kong MDACS registration information for Positive Airway Pressure Units, Bi-Level. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: Positive Airway Pressure Units, Bi-Level
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
20743
Product Code Detail
20743 Positive Airway Pressure Units, Bi-Level
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Respironics, Inc.
Respironics, Inc.
United States
็พๅฝ
1001 Murry Ridge Lane, Murrysville PA 15668, USA
1001 Murry Ridge Lane, Murrysville PA 15668, USA
Authorised Representative (AR)
28731887 / 28215111/ 26199663
Regulatory Timeline
Registration Date
May 12, 2023
Expiry Date
May 12, 2028
Product Models
DreamStation BiPAP ST (INX1025S19, INX1025H19, INX1025T19, INX1030S19, INX1030H19, INX1030T19), DreamStation BiPAP AVAPS (INX1125S19, INX1125H19, INX1125T19, INX1130S19, INX1130H19, INX1130T19, INX1131S19, INX1131H19, INX1131T19)
DreamStation BiPAP ST (INX1025S19, INX1025H19, INX1025T19, INX1030S19, INX1030H19, INX1030T19), DreamStation BiPAP AVAPS (INX1125S19, INX1125H19, INX1125T19, INX1130S19, INX1130H19, INX1130T19, INX1131S19, INX1131H19, INX1131T19)