Certificate of RegistrationQUALITY MANAGEMENT SYSTEM - ISO 13485:2016
This is to certify that:

Bio-Rad Laboratories (Shanghai)Co., Ltd.
Section C, 4F
No. 15 Workshop
No. 69, Xiya Road
Shanghai Free Trade Zone
Shanghai200131
China

Holds Certificate No:

MD 685143

伯乐生命医学产品(上海)有限公司
91310115736654349P
中国上海自由贸易试验区
希雅路69号
15号厂房
4层C部位
邮编：200131

and operates a Quality Management System which complies with the requirements of ISO 13485:2016 for thefollowing scope:
The provision of sales, after sales services, warehouse storage and logistics, labeling,
unpacking and repackaging for in vitro diagnostic medical devices, in vitro diagnostic reagent.
体外诊断医疗器械，体外诊断试剂的销售及售后服务、仓储物流、贴标，拆包装及再包装。

For and on behalf of BSI:
Gary E Slack, Senior Vice President - Medical Devices
Original Registration Date: 2019-01-15

Effective Date: 2022-01-15

Latest Revision Date: 2022-01-11

Expiry Date: 2025-01-14
Page: 1 of 4This certificate was issued electronically and remains the property of BSI and is bound by the conditions of contract.
An electronic certificate can be authenticated online.
Printed copies can be validated at www.bsi-global.com/ClientDirectory or telephone +86 10 8507 3000.
Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: +44 845 080 9000
BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.
A Member of the BSI Group of Companies.

Certificate No:MD 685143

Location

Registered Activities

Bio-Rad Laboratories (Shanghai)Co., Ltd.
Section C, 4F
No. 15 Workshop
No. 69, Xiya Road
Shanghai Free Trade Zone
Shanghai200131
China
伯乐生命医学产品(上海)有限公司
91310115736654349P中国上海自由贸易试验区
希雅路69号
15号厂房
4层C部位
邮编：200131

The provision of warehouse storage and logistics, labeling,unpacking and repackaging for in vitro diagnostic medicaldevices, in vitro diagnostic reagent.
体外诊断医疗器械，体外诊断试剂的仓储物流、贴标，拆包装
及再包装。

Bio-Rad Laboratories (Shanghai)Co., Ltd.
Shanghai Branch
Room 501,502, and 6F
No.168, Jingzhou Road
Yangpu District
Shanghai
200082
China
伯乐生命医学产品(上海)有限公司分公司
913101157989586208
中国上海杨浦区
荆州路168号
501，502室，6层整层
邮编：200082

The provision of sales, after sales services for in vitro
diagnostic medical devices, in vitro diagnostic reagent.
体外诊断医疗器械，体外诊断试剂的销售及售后服务。

Original Registration Date: 2019-01-15

Effective Date: 2022-01-15

Latest Revision Date: 2022-01-11

Expiry Date: 2025-01-14
Page: 2 of 4This certificate was issued electronically and remains the property of BSI and is bound by the conditions of contract.
An electronic certificate can be authenticated online.
Printed copies can be validated at www.bsi-global.com/ClientDirectory or telephone +86 10 8507 3000.
Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: +44 845 080 9000BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.
A Member of the BSI Group of Companies.

Certificate No:MD 685143

Location

Registered Activities

Bio-Rad Laboratories (Shanghai)Co., Ltd.
Beijing Branch
Room 101, 1F
Building 20
No. 10, Jiuxiaoqiao Road
Chaoyang District
Beijing
100015
China
伯乐生命医学产品(上海)有限公司北京分公司
911101056631012670
中国
北京
朝阳区酒仙桥路10号院
20号楼一层101室
邮编：100015

The provision of sales support, after sales services for in vitro
diagnostic medical devices, in vitro diagnostic reagent.

Bio-rad Laboratories (Shanghai)Co., Ltd.
Guangzhou Branch
Unit 02-03, 13F
No. 403, East Huanshi Road
Yuexiu District
Guangzhou
Guangdong
510095
China
伯乐生命医学产品(上海)有限公司广州分公司
91440101664019302U
中国广东省广州市
越秀区
环市东路403号
13层02-03单位
邮编：510095

The provision of sales support, after sales services for in vitro
diagnostic medical devices, in vitro diagnostic reagent.

体外诊断医疗器械，体外诊断试剂的销售支持及售后服务。

体外诊断医疗器械，体外诊断试剂的销售支持及售后服务。

Original Registration Date: 2019-01-15

Effective Date: 2022-01-15

Latest Revision Date: 2022-01-11

Expiry Date: 2025-01-14
Page: 3 of 4This certificate was issued electronically and remains the property of BSI and is bound by the conditions of contract.
An electronic certificate can be authenticated online.
Printed copies can be validated at www.bsi-global.com/ClientDirectory or telephone +86 10 8507 3000.
Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: +44 845 080 9000
BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.
A Member of the BSI Group of Companies.

Certificate No:

MD 685143

Location

Registered Activities

Bio-Rad Laboratories (Shanghai)Co., Ltd.
Wuhan Branch
Room 2008-2009
Wuhan Wuchang Wanda CenterNo.96, Linjiang Avenue, Wuchang District
Wuhan
Hubei
430060China
伯乐生命医学产品（上海）有限公司武汉分公司
91420000676461341N
中国
湖北省
武汉市
武昌区
临江大道96号
武汉武昌万达中心2008-2009室
邮编：430060

The provision of sales support, after sales services for in vitro
diagnostic medical devices, in vitro diagnostic reagent.

体外诊断医疗器械，体外诊断试剂的销售支持及售后服务。

Original Registration Date: 2019-01-15

Effective Date: 2022-01-15

Latest Revision Date: 2022-01-11

Expiry Date: 2025-01-14
Page: 4 of 4This certificate was issued electronically and remains the property of BSI and is bound by the conditions of contract.
An electronic certificate can be authenticated online.
Printed copies can be validated at www.bsi-global.com/ClientDirectory or telephone +86 10 8507 3000.
Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: +44 845 080 9000
BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.
A Member of the BSI Group of Companies.