United Kingdom MHRA device registration 166040

General specimen container IVD, no additive/medium

United Kingdom·In Vitro Diagnostic Device·Beckman Coulter Biomedical GmbH·Registered Nov 26, 2024

Registration details

Device ID: 166040
MHRA Reference Number: 166040
Date Registered: Nov 26, 2024
Last Updated: Nov 19, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: General specimen container IVD, no additive/medium
Type: Class A

Manufacturer

Name: Beckman Coulter Biomedical GmbH
Address: Sauerbruchstr. 50
Munich, Germany
Created Date: Dec 21, 2021

Authorized Representative

Name: Beckman Coulter UK Ltd
Relationship Type: UK Responsible Person
Address: Oakley Court Kingsmead Busines sPark London Rd
High Wycombe, Bucks, United Kingdom
Postcode: HP11 1JU

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 Beckman Coulter Biomedical GmbH

Additional devices registered by the same manufacturer

Clinical laboratory information system application softwareNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 166038

Specimen processing instrument IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 125646

General specimen container IVD, no additive/mediumNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 125647

Specimen processing instrument IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 166039

Other products from same authorized representative

Additional devices represented by Beckman Coulter UK Ltd in the UK

General specimen container IVD, no additive/mediumNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Beckman Coulter Biomedical GmbH

Device ID: 125647

Digitoxin therapeutic drug monitoring IVD, calibratorNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Beckman Coulter Ireland Inc.

Device ID: 187170

Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassayNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Beckman Coulter Inc.

Device ID: 172602

Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Beckman Coulter Inc.

Device ID: 172601

Clinical laboratory information system application softwareNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Normand - Info SASU

Device ID: 121125

Specimen processing instrument IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Beckman Coulter Biomedical GmbH

Device ID: 166039

Clinical laboratory information system application softwareNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Normand - Info SASU

Device ID: 175799

C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetryNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Beckman Coulter Inc.

Device ID: 205714

Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Beckman Coulter Inc.

Device ID: 172600

Digitoxin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetryNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Beckman Coulter Ireland Inc.

Device ID: 187173

About this record

General specimen container IVD, no additive/medium is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 166040. The device is manufactured by Beckman Coulter Biomedical GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Beckman Coulter 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