180111
IV
current
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This profile provides complete Hong Kong MDACS registration information for Prostheses, Cardiac Valve, Biological. 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: Prostheses, Cardiac Valve, Biological
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
15870
Product Code Detail
15870 Prostheses, Cardiac Valve, Biological
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Edwards Lifesciences LLC
Edwards Lifesciences
United States
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One Edwards Way, Irvine CA 92614, United States Of America
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Authorised Representative (AR)
31809428/36192691
Regulatory Timeline
Registration Date
March 03, 2023
Expiry Date
May 04, 2028
Product Models
Carpentier Edwards Perimount RSR Pericardial Bioprosthesis (2800TFX19MM, 2800TFX21MM, 2800TFX23MM, 2800TFX25MM, 2800TFX27MM, 2800TFX29MM), Carpentier Edwards Perimount Magna Ease Pericardial Bioprosthesis (3300TFX19MM, 3300TFX21MM, 3300TFX23MM, 3300TFX25MM, 3300TFX27MM, 3300TFX29MM), Carpentier Edwards Perimount Plus Pericardial Bioprosthesis (6900PTFX25, 6900PTFX27, 6900PTFX29, 6900PTFX31, 6900PTFX33), Carpentier Edwards Perimount Magna Mitral Ease Pericardial Bioprosthesis (7300TFX25, 7300TFX27, 7300TFX29, 7300TFX31, 7300TFX33)
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น Perimount Magna Ease ๅฟๅ
็็ฉๅไฝ (3300TFX19MM, 3300TFX21MM, 3300TFX23MM, 3300TFX23MM, 3 300TFX25MM, 3300TFX27MM, 3300TFX29MM), ๅกๅฝญ่ๅ็ฑๅพทๅๅ
นๅจ่พนๅ ๅฟๅ
็็ฉๅไฝ (6900PTFX25, 6900PTFX27, 6900PTFX29, 6900PTFX31, 6900PTFX33), ๅกๅฝญ่ๅ็ฑๅพทๅๅ
นๅจๅคงๅฐ็ฃไบๅฐ็ฃ็ผ่งฃๅฟๅ
็็ฉๅไฝ (7300TFX25, 7300TFX27ใ7300TFX29ใ7300TFX31ใ7300TFX33)