The document is a CE Technical Documentation Review Report from TUV Rheinland (China) Ltd. for Shenzhen Bio Cup BioTech Co., Ltd. It provides the applicant and product information, report number, intent of examination, product type and model, classification, examination period, and review result. The review found the technical documentation provided was complete and compliant with the requirements of the In Vitro Diagnostic Medical Devices Directive 98/79/EC Annex III.

1. Unit 707, AVIC Bldg., No. 10B, Central Road, East 3rd
Ring Road, Chaoyang District, Beijing, 100022, P.R.China
Tel：(8610)6566 6660 Fax: (8610)6566 6667
e-mail: info@bj.chn.tuv.com Internet: http://www.chn.tuv.com
CE Technical Documentation Review Report
Applicant: Shenzhen Bio Cup BioTech Co., Ltd.
End of South & North, Floor 2nd, Block 1st,
Aerospace Science Engineering Center, the 10th
Industrial Zone of You Song, Longhua New District,
Shenzhen City, Guangdong Province, China
Report Number: 16804424.001
Examination intent: Examination the completeness of the Technical
Documentation according to the requirements of the
In Vitro Diagnostic Medical Devices Directive
98/79/EC Annex III
Product(s): See the attachment
Type(s)/Model(s): ------
Classification: Other IVD products
(according to manufacturer’s declaration)
Examination period: Feb.04.2015
Date of expiry: Feb.03.2020
Review result: During the examination of the provided Technical
Documentation (No.:BK218 CE TF, Revision A/0,
Dated 2014-10-01) no Non-compliance according to
the requirements of the In Vitro Diagnostic Medical
Devices Directive 98/79/EC Annex III was detected.
TÜV Rheinland (China) Ltd.
Yuhong CHEN
Manager
Medical Services
Rev.01, 2002-10-10