United Kingdom MHRA device registration 118513

Haematological cell analyser IVD

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·SYSMEX CORPORATION·Registered Dec 8, 2021
Registration details
Device ID
118513
MHRA Reference Number
118513
Date Registered
Dec 8, 2021
Last Updated
Jan 19, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Haematological cell analyser IVD
Type
IVD General
Manufacturer
Address
1-5-1 Wakinohama-Kaigandori Chuo-Ku
Kobe, Hyogo, Japan
Created Date
Dec 8, 2021
Authorized Representative
Relationship Type
UK Responsible Person
Address
Unit 5 Oxford Technology Park 4a Technology Drive
Kidlington, Oxfordshire, England, United Kingdom
Postcode: OX5 1GN
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 SYSMEX CORPORATION

Additional devices registered by the same manufacturer

Other products from same authorized representative

Additional devices represented by OXFORD GENE TECHNOLOGY (OPERATIONS) LTD in the UK

About this record

Haematological cell analyser IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 118513. The device is manufactured by SYSMEX CORPORATION from Japan, classified as In Vitro Diagnostic Device. The authorized representative in the UK is OXFORD GENE TECHNOLOGY (OPERATIONS) 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