240043
IV
current
Stimulators, Electrical Neuromuscular, Obstructive Sleep Apnea, Implantableๅบๆฟๅจ,็ฅ็ป่่็ต,้ปๅกๆง็ก็ ๅผๅธๆๅ,ๆคๅ ฅๅผ
This profile provides complete Hong Kong MDACS registration information for Stimulators, Electrical Neuromuscular, Obstructive Sleep Apnea, Implantable. 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: Stimulators, Electrical Neuromuscular, Obstructive Sleep Apnea, Implantable
็ขๅ่ณ่จ๏ผ ๅบๆฟๅจ,็ฅ็ป่่็ต,้ปๅกๆง็ก็ ๅผๅธๆๅ,ๆคๅ ฅๅผ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
33843
Product Code Detail
33843 Stimulators, Electrical Neuromuscular, Obstructive Sleep Apnea, Implantable
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Inspire Medical Systems, Inc.
Inspire Medical Systems, Inc.
United States
็พๅฝ
5500 Wayzata Blvd, Suite 1600, Golden Valley, Minnesota 55416, USA
5500 Wayzata Blvd, Suite 1600, Golden Valley, Minnesota 55416, ็พๅฝ
Authorised Representative (AR)
Synapse Therapeutics Limited
็พ่ฐทๅป็็งๆๆ้ๅ
ฌๅธ
31881638
Regulatory Timeline
Registration Date
February 19, 2024
Expiry Date
February 18, 2029
Product Models
Inspire IV Implantable Pulse Generator, Model 3028, Inspire Sensing Lead, Model 4340 , Inspire Stimulation Lead, Model 4063 , Inspire Programmer, Model 2740 , Inspire Sleep Remote, Model 2500 , Inspire Sleep Remote, Model 2580
Inspire IV ๆคๅ
ฅๅผ่ๅฒๅ็ๅจ,ๅๅท 3028,Inspire ไผ ๆๅผ็บฟ,ๅๅท 4340,Inspire ๅบๆฟๅผ็บฟ,ๅๅท 4063,Inspire Programmer,ๅๅท 2740,Inspire ็ก็ ้ฅๆงๅจ,ๅๅท 2500,Inspire ็ก็ ้ฅๆงๅจ,ๅๅท 2580