SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 161891. The device is manufactured by NZYTech from Portugal, classified as In Vitro Diagnostic Device. The authorized representative in the UK is UKCA Experts Ltd..

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SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

MHRA Device ID: 161891•Ref: 161891

Device Type

In Vitro Diagnostic Device

Devices

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Type

IVD General

Date Registered

Nov 28, 2022

Last Updated

Nov 29, 2022

Manufacturer Information

Name

NZYTech

Address

Estrada do Paço do Lumiar, Campus do Lumiar, Edifício E – r/c

Lisboa, Portugal

Created Date

Nov 28, 2022

Authorized Representative

Name

UKCA Experts Ltd.

Relationship Type

UK Responsible Person

Address

Dept 302, 43 Owston Road Carcroft

Doncaster, England, United Kingdom

Postcode: DN6 8DA

DJ Fang

MedTech Regulatory Expert

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Other Products from NZYTech (1)

Nucleic acid extraction/isolation kit IVD

Type: In Vitro Diagnostic Device

Registered: Nov 28, 2022

Other Products from Same Authorized Representative (10)

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

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DJ Fang

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