United Kingdom MHRA device registration 155955

General specimen collection kit IVD, home-use

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Jiangsu Mole Bioscience Co., Ltd.·Registered Nov 26, 2024
Registration details
Device ID
155955
MHRA Reference Number
155955
Date Registered
Nov 26, 2024
Last Updated
Apr 26, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
General specimen collection kit IVD, home-use
Type
IVD General
Manufacturer
Address
6-7th Floor, G116 Building, No. 805, Jiankang Avenue Medical New & Hi-tech District, Taizhou
Jiangsu Province, China
Created Date
Mar 4, 2021
Authorized Representative
Relationship Type
UK Responsible Person
Address
3rd Floor, 70 Gracechurch Street
London, England, United Kingdom
Postcode: EC3V 0HR
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 Jiangsu Mole Bioscience Co., Ltd.

Additional devices registered by the same manufacturer

Other products from same authorized representative

Additional devices represented by SUNGO Certification Company Limited in the UK

Thermal cycler nucleic acid amplification analyser IVD, laboratoryNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Hangzhou Lifereal Biotechnology Co., Ltd.
Device ID: 90732
Nucleic acid sample preparation instrument IVD, semi-automatedNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Device ID: 132968
General specimen container IVD, additive/mediumNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Device ID: 138875
Thermal cycler nucleic acid amplification analyser IVD, laboratoryNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Device ID: 138876
General specimen container IVD, additive/mediumNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Device ID: 132970
Nucleic acid extraction/isolation kit IVDNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Device ID: 112099
Isothermal nucleic acid amplification analyser IVD, laboratory, automatedNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Guangzhou Pluslife Biotech Co., Ltd.
Device ID: 153636
Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Guangzhou Pluslife Biotech Co., Ltd.
Device ID: 155900
Nucleic acid extraction/isolation kit IVDNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Device ID: 138874
Thermal cycler nucleic acid amplification analyser IVD, laboratoryNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Device ID: 132969
About this record

General specimen collection kit IVD, home-use is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 155955. The device is manufactured by Jiangsu Mole Bioscience Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is SUNGO Certification Company 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