Pure Global
200336
II
current

Positive Airway Pressure Units, Continuousๆฐ”้“ๆญฃๅŽ‹้€šๆฐ”ๅ•ไฝ,่ฟž็ปญ

This profile provides complete Hong Kong MDACS registration information for Positive Airway Pressure Units, Continuous. 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, Continuous

็”ขๅ“่ณ‡่จŠ๏ผš ๆฐ”้“ๆญฃๅŽ‹้€šๆฐ”ๅ•ไฝ,่ฟž็ปญ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
11001
Product Code Detail
11001 Positive Airway Pressure Units, Continuous
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
1 Elizabeth Macarthur Drive, Bella Vista, NSW 2153, AUSTRALIA
1 ไผŠไธฝ่ŽŽ็™ฝ้บฆๅ…‹้˜ฟ็‘Ÿๅคง้“, ่ดๆ‹‰็ปดๆ–ฏๅก”, ๆ–ฐๅ—ๅจๅฐ”ๅฃซๅทž 2153, ๆพณๅคงๅˆฉไบš
Authorised Representative (AR)
Humana Medical Limited
ๅ–œๆ›ผๆ‹ฟๅŒป็–—็ณป็ปŸๆœ‰้™ๅ…ฌๅธ
28104868
Regulatory Timeline
Registration Date
October 21, 2020
Expiry Date
October 21, 2025
Product Models
AirSense 10 Autoset, AirSense 10 Autoset for Her
AirSense 10 ่‡ชๅŠจ่ฎพ็ฝฎ,AirSense 10 ่‡ชๅŠจ่ฎพ็ฝฎไธบๅฅน