Coagulation factor VIII IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

Coagulation factor VIII IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 145681. The device is manufactured by Affinity Biologicals Inc. from Canada, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Emergo Consulting (UK) Limited .

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Coagulation factor VIII IVD, kit, enzyme immunoassay (EIA)

MHRA Device ID: 145681•Ref: 145681

Device Type

In Vitro Diagnostic Device

Devices

Coagulation factor VIII IVD, kit, enzyme immunoassay (EIA)

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Apr 17, 2024

Manufacturer Information

Name

Affinity Biologicals Inc.

Address

1348 Sandhill Drive

Ancaster, Ontario, Canada

Created Date

Apr 22, 2022

Authorized Representative

Name

Emergo Consulting (UK) Limited

Relationship Type

UK Responsible Person

Address

Compass House, Vision Park Histon c/o Cr360 – UL International

Cambridge, England, United Kingdom

Postcode: CB24 9BZ

DJ Fang

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Other Products from Affinity Biologicals Inc. (2)

Coagulation factor IX IVD, kit, enzyme immunoassay (EIA)

Type: In Vitro Diagnostic Device

Registered: Nov 26, 2024

Multiple coagulation factor IVD, control

Type: In Vitro Diagnostic Device

Registered: Nov 26, 2024

Other Products from Same Authorized Representative (10)

Coagulation factor VIII IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

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