Pure Global
180021
III
current

Monitors, Physiologic, Fetal, Intrapartum, Bedside็›‘ๆŠคไปช, ็”Ÿ็†, ่ƒŽๅ„ฟ, ไบงๆ—ถ, ๅบŠ่พน

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

็”ขๅ“่ณ‡่จŠ๏ผš ็›‘ๆŠคไปช, ็”Ÿ็†, ่ƒŽๅ„ฟ, ไบงๆ—ถ, ๅบŠ่พน

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
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Edan Instruments, Inc.
ๆทฑๅœณๅธ‚็†้‚ฆ็ฒพๅฏ†ไปชๅ™จ่‚กไปฝๆœ‰้™ๅ…ฌๅธ
#15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District, 518122 Shenzhen, PEOPLE'S REPUBLIC OF CHINA
้‡‘ๆฒ™็คพๅŒบ้‡‘ๆฑ‡่ทฏ #15 ๅท, ๅชๅฑฑๅŒบๅ‘ๅญ่ก—้“, ๅชๅฑฑๅŒบ, 518122 ๆทฑๅœณๅธ‚, ไธญๅŽไบบๆฐ‘ๅ…ฑๅ’Œๅ›ฝ
Authorised Representative (AR)
Pengbang Medical (HK) Co., Limited
้น้‚ฆๅŒป็–—ๅ™จๆขฐ๏ผˆ้ฆ™ๆธฏ๏ผ‰ๆœ‰้™ๅ…ฌๅธ
66499391
Regulatory Timeline
Registration Date
February 20, 2023
Expiry Date
February 20, 2028
Product Models
Central Monitoring System (FTS-6)
ไธญๅคฎ็›‘ๆŽง็ณป็ปŸ (FTS-6)