Pure Global
90306
III
current

Monitors, Physiologic, Respiration/Exhaled Carbon Dioxide/Pulse Oximetry, Bedside็›‘ๆŠคไปช, ็”Ÿ็†, ๅ‘ผๅธ/ๅ‘ผๅ‡บไบŒๆฐงๅŒ–็ขณ/่„‰ๆ่ก€ๆฐง้ฅฑๅ’Œๅบฆ, ๅบŠๆ—

This profile provides complete Hong Kong MDACS registration information for Monitors, Physiologic, Respiration/Exhaled Carbon Dioxide/Pulse Oximetry, 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, Respiration/Exhaled Carbon Dioxide/Pulse Oximetry, Bedside

็”ขๅ“่ณ‡่จŠ๏ผš ็›‘ๆŠคไปช, ็”Ÿ็†, ๅ‘ผๅธ/ๅ‘ผๅ‡บไบŒๆฐงๅŒ–็ขณ/่„‰ๆ่ก€ๆฐง้ฅฑๅ’Œๅบฆ, ๅบŠๆ—

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
23717
Product Code Detail
23717 Monitors, Physiologic, Respiration/Exhaled Carbon Dioxide/Pulse Oximetry, 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
August 18, 2024
Expiry Date
August 17, 2029
Product Models
Vital Signs Monitor (M3B)
็”Ÿๅ‘ฝไฝ“ๅพ็›‘ๆŠคไปช (M3B)