160089
II
current
Centrifugal Blood Cell Processors, Autologous Platelet Separation็ฆปๅฟ่ก็ป่ๅค็ๅจ,่ชไฝ่กๅฐๆฟๅ็ฆป
This profile provides complete Hong Kong MDACS registration information for Centrifugal Blood Cell Processors, Autologous Platelet Separation. 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: Centrifugal Blood Cell Processors, Autologous Platelet Separation
็ขๅ่ณ่จ๏ผ ็ฆปๅฟ่ก็ป่ๅค็ๅจ,่ชไฝ่กๅฐๆฟๅ็ฆป
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
21995
Product Code Detail
21995 Centrifugal Blood Cell Processors, Autologous Platelet Separation
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Terumo BCT Inc.
Terumo Bct, Inc
United States
็พๅฝ
10811 W. Collins Ave, Lakewood, Colorado 80215, USA
10811 W.ๆฏๆๆฏๅคง้,่ฑๅ
ไผๅพท,็ง็ฝๆๅคๅท80215,็พๅฝ
Authorised Representative (AR)
Terumo China (Hong Kong) Limited
ๆณฐๅฐ่ไธญๅฝ(้ฆๆธฏ)ๆ้ๅ
ฌๅธ
28660811/ 25663393
Regulatory Timeline
Registration Date
May 26, 2021
Expiry Date
March 10, 2026
Product Models
SmartPrep Centrifuge and accessories (51470, 51478, 51474, 51482, 51472, 51480, 51475, 51483, 51488, 51489, 51490, 51491, 51492, 51493, 51452, 51453, 51454, 51451, 51487, 51486, 51494, 51495, 51498, 51499, 51496), Autologous Platelet Concentrate Procedure Pack (51402, 51403, 51404, 51405, 51406, 51407, 51408, 51409), Bone Marrow Aspirate Concentrate Procedure Pack (51416, 51417, 51418, 51420, 51421, 51422, 51423, 51424, 51425 ), Clear PRP (51410), AdiPrep Procedure Pack (51431, 51432, 51433, 51434, 51435), Graft Delivery Pack (51449, 51450), Platelet Concentrate Procedure Pack (51400, 51401)
SmartPrep ็ฆปๅฟๆบๅ้ไปถ(51470ใ51478ใ51474ใ51482ใ51472ใ51480ใ51475ใ51483ใ51488ใ51489ใ51490ใ51491ใ51492ใ51493ใ51452ใ51453ใ51454ใ51451ใ51487ใ51486ใ51494ใ51495ใ 51498, 51499, 51496), ่ชไฝๆต็ผฉ่กๅฐๆฟๆๆฏๅ
(51402, 51403, 51404, 51405, 51406, 51407, 51408, 51409), ้ชจ้ซๆฝๅธๆต็ผฉ็ฉๆๆฏๅ
(51416, 51417, 51418, 51420, 51421, 51422, 51423, 51424, 51425 ), ้ๆPRP (51410), AdiPrep็จๅบๅ
(51431, 51432, 51433, 51434, 51435), ็งปๆค็ฉ้้ๅ
(51449, 51450), ่กๅฐๆฟๆต็ผฉ็ฉ็จๅบๅ
(51400, 51401)