SRN registration

The full English name of SRN is single registration number, which refers to the unique identification of each economic operator on the EU medical device database eudamed and relevant official documents and reports. Generally speaking, SRN is the unique ID number of the manufacturer or importer in the eudamed system, which can realize various identification and traceability effects.

EU free sale certificate (FSC)

The content of the free sale certificate is usually to prove that the corresponding product is a legally produced and / or sold product that meets the requirements of local laws and regulations in the issuing country. At the same time, the regulatory authority of the destination country accepts the validity of the certificate issued by the issuing country to determine that it also meets the regulatory requirements of the destination country, or as one of its evidences.

Preparation of MDR CE technical documents

If the CE certificate conforming to the MDD standard expires during the transition period, and the CE certificate conforming to the MDR standard is not obtained during the transition period, your product must exit the EU market, and can be re launched only after the product has obtained the CE certificate conforming to the MDR standard.

EU HSC Common List

The list is currently the most authoritative list of antigen detection reagents in the EU region. The list was first published on February 17, 2021. After this update, a total of 83 covid-19 rapid antigen tests have been included in the common list, of which 35 test results have been mutually recognized by EU Member States.

IVDR CE certification

Ivdr will be enforced on May 26, 2022. Many in vitro diagnostic reagent manufacturers feel that it is still early, but vdear deeply feels that it is already late. Compared with the impact of MDR on medical device enterprises, ivdr has a greater impact on in vitro diagnostic reagent manufacturers. Why?

IVDD CE certification

Any medical device, including reagents, reagent products, calibration materials, control materials, kits, instruments, devices, equipment or systems, intended by the manufacturer for in vitro examination of samples obtained from human body, including blood and tissue donors, whether used alone or in combination,

EU authorized representative

In Article 15 of the MDR, it is clearly required that the medical device manufacturer shall at least have one person responsible for regulatory compliance within its organizational structure, that is, the person responsible for regulatory compliance. The personnel shall have the necessary professional knowledge in the field of medical devices and can pass any of the following qualification certificates

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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！

友情链接：国瑞质量检验中心

SRN registration

EU free sale certificate (FSC)

Preparation of MDR CE technical documents

EU HSC Common List

MDR CE certification

IVDR CE certification

IVDD CE certification

EU authorized representative