United Kingdom MHRA device registration 161892

Nucleic acid extraction/isolation kit IVD

United Kingdom·In Vitro Diagnostic Device·NZYTech·Registered Nov 28, 2022

Registration details

Device ID: 161892
MHRA Reference Number: 161892
Date Registered: Nov 28, 2022
Last Updated: Nov 29, 2022

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Nucleic acid extraction/isolation kit IVD
Type: IVD General

Manufacturer

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

Similar products

Devices with a matching generic name or device type registered with MHRA

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176179

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176185

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175386

Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176184

C-reactive protein (CRP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176164

Cryptosporidium species antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176139

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175389

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testingN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175394

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175395

D-dimer IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176162

Other products from NZYTech

Additional devices registered by the same manufacturer

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 28, 2022

Type: In Vitro Diagnostic Device

Device ID: 161891

Other products from same authorized representative

Additional devices represented by UKCA Experts Ltd. in the UK

Pliable-polymer dental regeneration membrane, bioabsorbable, tackedNov 26, 2024

Type: General Medical Device

Manufacturer: Cowellmedi

Device ID: 121892

Mental health/function therapeutic software, screen-viewedNov 26, 2024

Type: General Medical Device

Manufacturer: MindDoc Health GmbH

Device ID: 155595

Dental/maxillofacial surgical procedure kit, non-medicated, reusableNov 26, 2024

Type: General Medical Device

Manufacturer: Cowellmedi

Device ID: 121889

Surgical/medical respirator, antimicrobialNov 26, 2024

Type: General Medical Device

Manufacturer: Profit Royal Pharmaceutical Limited

Device ID: 141563

Breast implant delivery funnel, manualNov 26, 2024

Type: General Medical Device

Manufacturer: Kimsmed Co., Ltd.

Device ID: 121884

Medical equipment drape, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Exact Medical Manufacturing

Device ID: 169652

Breast implant delivery funnel, manualNov 26, 2024

Type: General Medical Device

Manufacturer: Kimsmed Co., Ltd.

Device ID: 190821

Self-care monitoring/reporting softwareNov 26, 2024

Type: General Medical Device

Manufacturer: Biowink GmbH

Device ID: 174180

Safe environment patient enclosureNov 26, 2024

Type: General Medical Device

Manufacturer: Human Protection B.V.

Device ID: 204049

Nasal breathing aid, internal, reusableNov 26, 2024

Type: General Medical Device

Manufacturer: Airmax BV

Device ID: 169157

About this record

Nucleic acid extraction/isolation kit IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 161892. The device is manufactured by NZYTech from Portugal, classified as In Vitro Diagnostic Device. The authorized representative in the UK is UKCA Experts Ltd..

This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, authorized representative details, and related products. Pure Global AI offers free access to 150,962+ UK MHRA medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free DatabasePowered by Pure Global AIMHRA RegisteredIn Vitro Diagnostic Device