Pure Global
180149
III
current

Heart-Lung Bypass Unitsๅฟƒ่‚บๆ—่ทฏ่ฃ…็ฝฎ

This profile provides complete Hong Kong MDACS registration information for Heart-Lung Bypass Units. 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: Heart-Lung Bypass Units

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
11969
Product Code Detail
11969 Heart-Lung Bypass Units
State
current
Status
N/A
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Manufacturer (่ฃฝ้€ ๅ•†)
Terumo Cardiovascular Systems Corp.
Terumo Cardiovascular Systems Corp.
United States
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6200 Jackson Road, Ann Arbor, Michigan 48103, USA
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Authorised Representative (AR)
Terumo China (Hong Kong) Limited
ๆณฐๅฐ”่Œ‚ไธญๅ›ฝ(้ฆ™ๆธฏ)ๆœ‰้™ๅ…ฌๅธ
28660811/ 25663393
Regulatory Timeline
Registration Date
June 11, 2023
Expiry Date
June 11, 2028
Product Models
Advanced Perfusion System 1 (5773, 5785, 5791, 5793, 6382, 16426, 131115, 144207, 144215, 144223, 145980, 146819, 149876, 150826, 164267, 164268, 164278, 195215, 195240, 195274, 217390, 801016, 801093, 801238, 801327, 801407, 801441, 801550, 801558, 801763, 801764, 802018, 802089, 802110, 802111, 802112, 802113, 802114, 802558, 803479, 803480, 803730, 803739, 803740, 804085, 804372, 804981, 804982, 806455, 814474, 814475, 815453, 816261, 816300, 816370, 816477, 816483, 816489, 816570, 816571, 816572, 816620, 822763, 16553301, 16553401)
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