190413
II
current
Electrocardiographs, Ambulatoryๅฟ็ตๅพไปช,้จ่ฏ
This profile provides complete Hong Kong MDACS registration information for Electrocardiographs, 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.
Product Info: Electrocardiographs, Ambulatory
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
18360
Product Code Detail
18360 Electrocardiographs, Ambulatory
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Rooti Labs Ltd.
Rooti Labs Ltd.
Taiwan
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5F-1, No.71, Zhouzi St., Neihu Dist., Taipei City 11493, Taiwan
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Authorised Representative (AR)
Sinomed Company Ltd.
ไธญไปชๆ้ๅ
ฌๅธ
28877640
Regulatory Timeline
Registration Date
December 11, 2019
Expiry Date
December 11, 2024
Product Models
Rooti Rx System (RXPE01)
Rooti Rx System (RXPE01)