United Kingdom MHRA device registration 92446

Buffered sample diluent IVD, automated/semi-automated system

United Kingdom·In Vitro Diagnostic Device·Nihon Kohden Firenze S.r.l.·Registered Nov 26, 2024

Registration details

Device ID: 92446
MHRA Reference Number: 92446
Date Registered: Nov 26, 2024
Last Updated: Aug 13, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Buffered sample diluent IVD, automated/semi-automated system
Type: IVD General

Manufacturer

Name: Nihon Kohden Firenze S.r.l.
Address: Via Torta 72/74
Sesto Fiorentino Firenze, FI Florence, Italy
Created Date: Aug 5, 2021

Authorized Representative

Name: NIHONKOHDEN UK LTD
Relationship Type: UK Responsible Person
Address: Unit 3, Heyworth Business Park Old Portsmouth Road, Peasmarsh GUILDFORD
GUILDFORD, Surrey, England, United Kingdom
Postcode: GU3 1AF

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 Nihon Kohden Firenze S.r.l.

Additional devices registered by the same manufacturer

Blood cell lysis reagent IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 92448

Wash/cleaning solution IVD, automated/semi-automated systemNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 92447

Other products from same authorized representative

Additional devices represented by NIHONKOHDEN UK LTD in the UK

General-purpose multi-parameter bedside monitorNov 26, 2024

Type: General Medical Device

Manufacturer: Shanghai Kohden Medical Electronic Instrument Corp.

Device ID: 95041

Portable/mobile rechargeable battery packNov 26, 2024

Type: General Medical Device

Manufacturer: Shanghai Kohden Medical Electronic Instrument Corp.

Device ID: 126494

Centralized patient monitorNov 26, 2024

Type: General Medical Device

Manufacturer: NIHON KOHDEN CORPORATION

Device ID: 126526

Centralized patient monitorNov 26, 2024

Type: General Medical Device

Manufacturer: NIHON KOHDEN CORPORATION

Device ID: 95321

Electrocardiograph, professional, multichannelNov 26, 2024

Type: General Medical Device

Manufacturer: NIHON KOHDEN CORPORATION

Device ID: 126509

Electrocardiographic electrode, reusableNov 26, 2024

Type: General Medical Device

Manufacturer: NIHON KOHDEN CORPORATION

Device ID: 126529

Electrocardiographic electrode, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: NIHON KOHDEN CORPORATION

Device ID: 126518

Electrocardiography monitoring system receiverNov 26, 2024

Type: General Medical Device

Manufacturer: NIHON KOHDEN CORPORATION

Device ID: 95315

Electrocardiography telemetric monitoring system transmitterNov 26, 2024

Type: General Medical Device

Manufacturer: NIHON KOHDEN CORPORATION

Device ID: 95316

Centralized patient monitorNov 26, 2024

Type: General Medical Device

Manufacturer: Shanghai Kohden Medical Electronic Instrument Corp.

Device ID: 95043

About this record

Buffered sample diluent IVD, automated/semi-automated system is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 92446. The device is manufactured by Nihon Kohden Firenze S.r.l. from Italy, classified as In Vitro Diagnostic Device. The authorized representative in the UK is NIHONKOHDEN UK 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