180021
III
current
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This profile provides complete Hong Kong MDACS registration information for Monitors, Physiologic, Fetal, Intrapartum, Bedside. 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: Monitors, Physiologic, Fetal, Intrapartum, Bedside
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
18340
Product Code Detail
18340 Monitors, Physiologic, Fetal, Intrapartum, Bedside
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Edan Instruments, Inc.
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ฌๅธ
#15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District, 518122 Shenzhen, PEOPLE'S REPUBLIC OF CHINA
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ฑๅๅฝ
Authorised Representative (AR)
Pengbang Medical (HK) Co., Limited
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ฌๅธ
66499391
Regulatory Timeline
Registration Date
February 20, 2023
Expiry Date
February 20, 2028
Product Models
Central Monitoring System (FTS-6)
ไธญๅคฎ็ๆง็ณป็ป (FTS-6)

