Creatine?kinase?myocardial?isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay - UK MHRA Medical Device Registration

Creatine?kinase?myocardial?isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 173404. The device is manufactured by Shenzhen Kinghi Biotechnology 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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Creatine?kinase?myocardial?isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay

MHRA Device ID: 173404•Ref: 173404

Device Type

In Vitro Diagnostic Device

Devices

Creatine?kinase?myocardial?isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay

Type

IVD General

Date Registered

May 24, 2024

Last Updated

Mar 13, 2024

Manufacturer Information

Name

Shenzhen Kinghi Biotechnology Co., Ltd.

Address

3B-1601, building 3, hengtaiyu building, Tangwei community, Fenghuang street, Guangming District

Shenzhen, China

Created Date

Jun 2, 2023

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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Creatine?kinase?myocardial?isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay - UK MHRA Medical Device Registration

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