United Kingdom MHRA device registration 177542

Nucleic acid sample preparation instrument IVD

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Zinexts Life Science Corp.·Registered Nov 22, 2024
Registration details
Device ID
177542
MHRA Reference Number
177542
Date Registered
Nov 22, 2024
Last Updated
Oct 12, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Nucleic acid sample preparation instrument IVD
Type
Class A
Manufacturer
Address
16F., No. 93, Sec. 1, Xintai 5th Rd., Xizhi Dist.,
New Taipei City, Taiwan
Created Date
Feb 15, 2022
Authorized Representative
Relationship Type
UK Responsible Person
Address
16 Castle St.
Dover, Kent, England, United Kingdom
Postcode: CT16 1PW
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 Zinexts Life Science Corp.

Additional devices registered by the same manufacturer

Other products from same authorized representative

Additional devices represented by Wellkang Ltd in the UK

About this record

Nucleic acid sample preparation instrument IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 177542. The device is manufactured by Zinexts Life Science Corp. from Taiwan, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Wellkang 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