D-dimer IVD, kit, fluorescent immunoassay - UK MHRA Medical Device Registration

D-dimer IVD, kit, fluorescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 168983. The device is manufactured by Boditech Med Inc. from South Korea, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Obelis UK Ltd.

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D-dimer IVD, kit, fluorescent immunoassay

MHRA Device ID: 168983•Ref: 168983

Device Type

In Vitro Diagnostic Device

Devices

D-dimer IVD, kit, fluorescent immunoassay

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Mar 20, 2024

Manufacturer Information

Name

Boditech Med Inc.

Address

43, Geodudanji 1-gil, Dongnae-myeon, Chuncheon-si, Gang-won-do 24398, Republic of Korea

Chuncheon-si, South Korea

Created Date

Mar 22, 2023

Authorized Representative

Name

Obelis UK Ltd

Relationship Type

UK Responsible Person

Address

Sandford Gate, East Point Business Park

Oxford , England, United Kingdom

Postcode: OX4 6LB

DJ Fang

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D-dimer IVD, kit, fluorescent immunoassay - UK MHRA Medical Device Registration

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Date Registered

Last Updated

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Created Date

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