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 154974. The device is manufactured by Goldsite Diagnostics Inc. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is CMC Medical Devices LTD.

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In Vitro Diagnostic Device

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

MHRA Device ID: 154974•Ref: 154974

Device Type

In Vitro Diagnostic Device

Devices

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

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Jan 5, 2024

Manufacturer Information

Name

Goldsite Diagnostics Inc.

Address

No. 1001, Building No.1, GOLDSITE Mansion, No. 9 Rongtian Road, Kengzi, Pingshan District

Shenzhen, Guangdong, China

Created Date

Aug 23, 2022

Authorized Representative

Name

CMC Medical Devices LTD

Relationship Type

UK Responsible Person

Address

Office 32 19-21 Crawford Street

London, United Kingdom

Postcode: W1H 1PJ

DJ Fang

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

Device Type

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Created Date

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Address

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