SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 87426. The device is manufactured by BioTeke Corporation (Wuxi) Co., Ltd from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is SUNGO Certification Company Limited.

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SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical

MHRA Device ID: 87426•Ref: 87426

Device Type

In Vitro Diagnostic Device

Devices

SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Apr 26, 2024

Manufacturer Information

Name

BioTeke Corporation (Wuxi) Co., Ltd

Address

4th Floor, D5 & 2nd Floor, D3 & 1st and 2nd Floor, D16 No. 1719, Huishan Avenue, Wuxi

Jiangsu Province, China

Created Date

Mar 3, 2021

Authorized Representative

Name

SUNGO Certification Company Limited

Relationship Type

UK Responsible Person

Address

3rd Floor, 70 Gracechurch Street

London, England, United Kingdom

Postcode: EC3V 0HR

DJ Fang

MedTech Regulatory Expert

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SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

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Created Date

Name

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Address

DJ Fang

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