Pure Global AI
Medical Device Division · registration 200336Active

ResMed

Hong KongPositive Airway Pressure Units, ContinuousClass IIResMed Pty Ltd
Official record identity
MDACS listing number
200336
Model name
AirSense 10 Autoset, AirSense 10 Autoset for Her
Registration date
July 03, 2025
Expiry date
October 20, 2030
Source update date
September 17, 2025
Status
Active
Official value: Valid
Classification
Risk class
Class II
Official value: II
Published category
Positive Airway Pressure Units, Continuous
Published parties
Registrant / registration holder
Humana Medical Limited
Manufacturer
ResMed Pty Ltd
Official description

Positive Airway Pressure Units, Continuous

Additional source fields
AMD nomenclature code
11001
Traditional Chinese local responsible person
喜曼拿醫療系統有限公司
Local responsible person phone
28104868
Published manufacturer address
1 Elizabeth Macarthur Drive, Bella Vista, NSW 2153, AUSTRALIA
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.