United Kingdom MHRA device registration 114563

Laboratory analyser cuvette IVD, single-use

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Roche Diagnostics GmbH·Registered Nov 26, 2024
Registration details
Device ID
114563
MHRA Reference Number
114563
Date Registered
Nov 26, 2024
Last Updated
Oct 10, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Laboratory analyser cuvette IVD, single-use
Type
Class A
Manufacturer
Address
Sandhofer Strasse 116
Mannheim, Germany
Created Date
Apr 19, 2021
Authorized Representative
Relationship Type
UK Responsible Person
Address
Roche Diagnostics Limited Charles Avenue
Burgess Hill, West Sussex, United Kingdom
Postcode: RH15 9RY
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 Roche Diagnostics GmbH

Additional devices registered by the same manufacturer

Other products from same authorized representative

Additional devices represented by Roche Diagnostics Limited in the UK

25-Hydroxy vitamin D3 IVD, calibratorNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Roche Diagnostics GmbH
Device ID: 107434
25-Hydroxy vitamin D3 IVD, reagentNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Roche Diagnostics GmbH
Device ID: 108421
Activated partial thromboplastin time (APTT) IVD, kit, rapid clotting, clinicalNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Roche Diagnostics GmbH
Device ID: 116420
Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometryNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Roche Diagnostics GmbH
Device ID: 115362
Albumin IVD, kit, nephelometry/turbidimetryNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Roche Diagnostics GmbH
Device ID: 115360
Albumin IVD, kit, spectrophotometryNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Roche Diagnostics GmbH
Device ID: 115359
Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetryNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Roche Diagnostics GmbH
Device ID: 108362
Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetryNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Roche Diagnostics GmbH
Device ID: 115353
Alpha-fetoprotein (AFP) IVD, calibratorNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Roche Diagnostics GmbH
Device ID: 95002
Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassayNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Roche Diagnostics GmbH
Device ID: 108373
About this record

Laboratory analyser cuvette IVD, single-use is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 114563. The device is manufactured by Roche Diagnostics GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Roche Diagnostics Limited.

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