United Kingdom MHRA device registration 159549

D-dimer IVD, kit, fluorescent immunoassay

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·VivaChek Biotech (Hangzhou) Co., Ltd.·Registered Nov 26, 2024
Registration details
Device ID
159549
MHRA Reference Number
159549
Date Registered
Nov 26, 2024
Last Updated
Jun 11, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
D-dimer IVD, kit, fluorescent immunoassay
Type
IVD General
Manufacturer
Address
Level 2, Block 2, 146 East Chaofeng Rd., Yuhang Economy Development Zone,
Hangzhou, Zhejiang, China
Created Date
Mar 14, 2021
Authorized Representative
Relationship Type
UK Responsible Person
Address
23 Maine Street
Reading, Reading, England, United Kingdom
Postcode: RG2 6AG
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 VivaChek Biotech (Hangzhou) Co., Ltd.

Additional devices registered by the same manufacturer

Other products from same authorized representative

Additional devices represented by lotus global co ltd in the UK

About this record

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 159549. The device is manufactured by VivaChek Biotech (Hangzhou) Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is lotus global co 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