United Kingdom MHRA device registration 133458

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

United Kingdom·In Vitro Diagnostic Device·CareHealth America Corporation dba Express Diagnostics Int'l, Inc.·Registered Nov 26, 2024

Registration details

Device ID: 133458
MHRA Reference Number: 133458
Date Registered: Nov 26, 2024
Last Updated: Nov 5, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Type: IVD General

Manufacturer

Name: CareHealth America Corporation dba Express Diagnostics Int'l, Inc.
Address: 1550 Industrial Drive Blue Earth,
Blue Earth, Minnesota, United States
Created Date: Jan 21, 2022

Authorized Representative

Name: lotus global co ltd
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 same authorized representative

Additional devices represented by lotus global co ltd in the UK

ENFit oral/enteral syringe, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: BQ PLUS MEDICAL CO.,LTD

Device ID: 145744

Endoscopic electrosurgical handpiece/electrode, bipolar, reusableNov 26, 2024

Type: General Medical Device

Manufacturer: Hangzhou Kangji Medical Instrument Co., Ltd.

Device ID: 77182

Laparoscopic wound closure threadNov 26, 2024

Type: General Medical Device

Manufacturer: Hangzhou Kangji Medical Instrument Co., Ltd.

Device ID: 165957

Ligation clip, metallicNov 26, 2024

Type: General Medical Device

Manufacturer: Hangzhou Kangji Medical Instrument Co., Ltd.

Device ID: 77188

Ligation clip, synthetic polymer, non-bioabsorbableNov 26, 2024

Type: General Medical Device

Manufacturer: Hangzhou Kangji Medical Instrument Co., Ltd.

Device ID: 77189

Open-surgery ligation clip applierNov 26, 2024

Type: General Medical Device

Manufacturer: Hangzhou Kangji Medical Instrument Co., Ltd.

Device ID: 165955

Simple pneumoperitoneum needleNov 26, 2024

Type: General Medical Device

Manufacturer: Hangzhou Kangji Medical Instrument Co., Ltd.

Device ID: 165954

Spring-loaded pneumoperitoneum needle, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Hangzhou Kangji Medical Instrument Co., Ltd.

Device ID: 77186

Surgical irrigation/aspiration handpiece, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Hangzhou Kangji Medical Instrument Co., Ltd.

Device ID: 77190

Endoscopic bite block, basic, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Transmed (China) Co., Ltd.

Device ID: 105505

About this record

Multiple drugs of abuse IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 133458. The device is manufactured by CareHealth America Corporation dba Express Diagnostics Int'l, Inc. from United States, 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