United Kingdom MHRA device registration 148500

Rotavirus antigen IVD, kit, rapid ICT, clinical

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Shanghai Homelabs Medical Co., Ltd·Registered Nov 26, 2024
Registration details
Device ID
148500
MHRA Reference Number
148500
Date Registered
Nov 26, 2024
Last Updated
Jan 13, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Rotavirus antigen IVD, kit, rapid ICT, clinical
Type
IVD General
Manufacturer
Address
Room 301, No. 5, Lane 88, Shengrong Road, China (Shanghai) Pilot Free Trade Zone.
Shanghai , China
Created Date
May 25, 2022
Authorized Representative
Relationship Type
UK Responsible Person
Address
Stirling House Cambridge Innovation Park, Denny End Road, Waterbeach
Cambridge, Cambridgeshire, United Kingdom
Postcode: CB25 9QE
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 Shanghai Homelabs Medical Co., Ltd

Additional devices registered by the same manufacturer

Other products from same authorized representative

Additional devices represented by NPZ technology Ltd in the UK

Nucleic acid sample preparation instrument IVDNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Wuxi Techstar Technology Co.,Ltd
Device ID: 132017
Endoscopic bite block, basic, single-useNov 26, 2024
Type: General Medical Device
Manufacturer: Changzhou Health Microport Medical Device Co., Ltd.
Device ID: 153246
Flexible endoscopic biopsy forceps, single-useNov 26, 2024
Type: General Medical Device
Manufacturer: Changzhou Health Microport Medical Device Co., Ltd.
Device ID: 173473
Oesophageal bougie, single-useNov 26, 2024
Type: General Medical Device
Manufacturer: Changzhou Health Microport Medical Device Co., Ltd.
Device ID: 153247
First aid absorbent pad/bandageNov 26, 2024
Type: General Medical Device
Manufacturer: Changzhou Major Medical Products Co., LTD
Device ID: 113343
Skin-cover adhesive strip, non-antimicrobialNov 26, 2024
Type: General Medical Device
Manufacturer: Changzhou Major Medical Products Co., LTD
Device ID: 201306
Synthetic polymer semi-permeable film dressing, adhesiveNov 26, 2024
Type: General Medical Device
Manufacturer: Changzhou Major Medical Products Co., LTD
Device ID: 201307
Dental digital imaging sensor, intraoralNov 26, 2024
Type: General Medical Device
Manufacturer: Changzhou Sifary Medical Technology Co., Ltd.,
Device ID: 201733
Dental power tool system handpiece, battery-poweredNov 26, 2024
Type: General Medical Device
Manufacturer: Changzhou Sifary Medical Technology Co., Ltd.,
Device ID: 86830
Laboratory container/microscope slide robotic transfer system IVDNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Wuxi Techstar Technology Co.,Ltd
Device ID: 132020
About this record

Rotavirus antigen IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 148500. The device is manufactured by Shanghai Homelabs Medical Co., Ltd from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is NPZ technology 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