Pure Global
230431
III
current

Monitoring Systems, Physiologic, Acute Care็›‘ๆต‹็ณป็ปŸ,็”Ÿ็†,ๆ€ฅๆ€งๆŠค็†

This profile provides complete Hong Kong MDACS registration information for Monitoring Systems, Physiologic, Acute Care. 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: Monitoring Systems, Physiologic, Acute Care

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
12647
Product Code Detail
12647 Monitoring Systems, Physiologic, Acute Care
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
United States
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9900 Innovation Drive, Wauwatosa, WI 53226, USA
9900ๅˆ›ๆ–ฐ้ฉฑๅŠจๅ™จ, ๆฒƒ็“ฆๆ‰˜่จ, WI 53226, ็พŽๅ›ฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
November 22, 2023
Expiry Date
November 22, 2028
Product Models
CARESCAPE ONE MBZ323 (2087075-300), CARESCAPE DOCK F0 (2062475-001), CARESCAPE ECG MKE101 (2099884-001), CARESCAPE INVASIVE PRESSURE MKP101 (2099660-001), CARESCAPE TEMPERATURE MKT101 (2099661-001), CARESCAPE SPO2 MKS101 - TRUSIGNAL 1,8M (2099662-001), CARESCAPE SPO2 MKS201 - TRUSIGNAL 3,0M (2099662-002)
CARESCAPE ONE MBZ323 (2087075-300), CARESCAPE DOCK F0 (2062475-001), CARESCAPE ๅฟƒ็”ตๅ›พ MKE101 (2099884-001), CARESCAPE ๆœ‰ๅˆ›ๅŽ‹ๅŠ› MKP101 (2099660-001), CARESCAPE ๆธฉๅบฆ MKT101 (2099661-001), CARESCAPE SPO2 MKS101 - TRUSIGNAL 1,8M (2099662-001), CARESCAPE SPO2 MKS201 - TRUSIGNAL 3,0M (2099662-002)