240410
II
current
Recorders, Electrocardiograph/Blood Pressure, Ambulatory่ฎฐๅฝไปชใๅฟ็ตๅพไปช/่กๅใๅจๆ
This profile provides complete Hong Kong MDACS registration information for Recorders, Electrocardiograph/Blood Pressure, Ambulatory. 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.
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
N/A
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Edan Instruments, Inc.
ๆทฑๅณๅธ็้ฆ็ฒพๅฏไปชๅจ่กไปฝๆ้ๅ
ฌๅธ
#15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District, 518122 Shenzhen, PEOPLE'S REPUBLIC OF CHINA
้ๆฒ็คพๅบ้ๆฑ่ทฏ #15 ๅท, ๅชๅฑฑๅบๅๅญ่ก้, ๅชๅฑฑๅบ, 518122 ๆทฑๅณๅธ, ไธญๅไบบๆฐๅ
ฑๅๅฝ
Authorised Representative (AR)
Pengbang Medical (HK) Co., Limited
้น้ฆๅป็ๅจๆขฐ๏ผ้ฆๆธฏ๏ผๆ้ๅ
ฌๅธ
66499391
Regulatory Timeline
Registration Date
September 24, 2024
Expiry Date
September 23, 2029
Product Models
Holter ECG and ABP system (SA-20, SA-19, SA-18, SA-16, SA-15)
ๅจๆๅฟ็ตๅพๅ ABP ็ณป็ป(SA-20ใSA-19ใSA-18ใSA-16ใSA-15)