Apheresis Units血液分离单位

This profile provides complete Hong Kong MDACS registration information for Apheresis 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: Apheresis Units

產品資訊： 血液分离单位

Device Overview

Hong Kong MDACS registration summary and classification details.

Risk Class

III

Product Code

16405

Product Code Detail

16405 Apheresis Units

State

Expired.

Status

N/A

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Manufacturer (製造商)

Terumo BCT Inc.

Terumo Bct, Inc

United States

美国

10811 W. Collins Ave., Lakewood, Colorado 80215, USA

10811 W.柯林斯大道,莱克伍德,科罗拉多州80215,美国

Authorised Representative (AR)

Terumo BCT (Hong Kong) Limited

泰尔茂比司特（香港）有限公司

97329061

Regulatory Timeline

Registration Date

September 28, 2016

Expiry Date

September 28, 2021

Product Models

COBE Spectra Apheresis System (71002, 70010, 70630, 70100, 70610, 70300, 70310, 70400, 70500, 70600, 70700, 70620, 70629, 70051, 70040, 777034-357, 70030, 950200-000, 956200-000, 956100-000, 958000-000, 71200, 957000-000, 951000-000, 71100, 953000-002, IFT40410)

COBE 光谱单采系统(71002、70010、70630、70100、70610、70300、70310、70400、70500、70600、70700、70620、70629、70051、70040、777034-357、70030、950200-000、956200-000、956100-000、958000-000、71200、957000-000、951000-000、71100、953000-002、IFT40410)