.png)
自测版试剂盒的认证模式可选择Annex III, Section 6的认证模式，即设计审查证书，参照法规可得知，此认证模式并不要求制造商必须提供ISO13485认证证书。如制造商选择全面质量保证声明的认证模式的话，则需具备ISO13485认证。
目前我司办理的自测ce认证证书为Annex III, Section 6的认证模式，企业提供相关体系文件即可，不要求必须得有证书。
Grzan News
.jpg "62500c9c1e414(1).jpg")
Tel：0755-33509057
Adress：Room 103-108, Building B, Block 2, Bangkai Science and Technology Park, No. 9, Guangyuan 5th Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province, China.
E-mail：hitolin@grzan.com
Grzan medical can undertake the whole process of technical guidance and services such as prospective clinical, who Eul, variant virus research (Delta, Omicron ba.1, ba.2), IVDD CE, ivdr CE, Australian TGA, British CTDA, European HSC common list, European service, British service, etc.
If you have products that have been tested and certified or want to know more about them, please contact Grzan medical！
Popular keywords：UK authorised representative CTDA registration HSC EU common list Canada cmdcas certification Canadian del certification Australian TGA certification Registered in Hong Kong Medical device certification Variant strain test Who Eul application IVDD CE certification IVDR CE认证 EU authorized representative SRN registration Ukca certification
友 情 链 接：国瑞质量检验中心
Copyright © Grzan medical technology (SZ) Co., Ltd All rights reserved