Pure Global
190154
III
current

Monitors, Physiologic, Blood Gas/pH, Bedside, Extracorporeal็›‘ๆŠคไปช, ็”Ÿ็†, ่ก€ๆฐ”/pH ๅ€ผ, ๅบŠๆ—, ไฝ“ๅค–

This profile provides complete Hong Kong MDACS registration information for Monitors, Physiologic, Blood Gas/pH, Bedside, Extracorporeal. 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, Blood Gas/pH, Bedside, Extracorporeal

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
17680
Product Code Detail
17680 Monitors, Physiologic, Blood Gas/pH, Bedside, Extracorporeal
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Terumo Cardiovascular Systems Corp.
Terumo Cardiovascular Systems Corp.
United States
็พŽๅ›ฝ
6200 Jackson Road, Ann Arbor, Michigan, 48103, USA
6200 Jackson Road, ๅฎ‰ๅจœๅ ก, ๅฏ†ๆญ‡ๆ นๅทž, 48103, USA
Authorised Representative (AR)
Terumo China (Hong Kong) Limited
ๆณฐๅฐ”่Œ‚ไธญๅ›ฝ(้ฆ™ๆธฏ)ๆœ‰้™ๅ…ฌๅธ
28660811/ 25663393
Regulatory Timeline
Registration Date
March 21, 2024
Expiry Date
June 04, 2029
Product Models
CDI Blood Parameter Monitoring System 550 (550AHCT, 550AVHCT, 540)
CDI ่ก€ๆถฒๅ‚ๆ•ฐ็›‘ๆต‹็ณป็ปŸ 550 (550AHCT, 550AVHCT, 540)