Urine analyser IVD, laboratory - UK MHRA Medical Device Registration
Urine analyser IVD, laboratory is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 175505. The device is manufactured by URIT Medical Electronic Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Wellkang 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.
Device Type
In Vitro Diagnostic Device
Devices
Urine analyser IVD, laboratory
Type
Class A
Date Registered
Nov 26, 2024
Last Updated
Aug 31, 2024
Address
No. D-07 Information Industry District High-Tech Zone
Guilin, Guangxi, China
Created Date
May 14, 2021
Name
Wellkang LtdRelationship Type
Address
16 Castle St.
Dover, Kent, England, United Kingdom
Postcode: CT16 1PW
Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
C-reactive protein (CRP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Cryptosporidium species antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
D-dimer IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Reticulocyte count IVD, kit, cell count
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Dental/surgical polymerization lamp
Type: General Medical Device
Registered: Nov 26, 2024
Full blood count IVD, calibrator
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Glucose analyser IVD, home-use
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Haematological cell analyser IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Instrument/analyser cleaning agent IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Lactate IVD, control
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Multiple urine analyte IVD, control
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Ultrasonic dental scaling/debridement system
Type: General Medical Device
Registered: Nov 26, 2024
Buffered sample diluent IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Isocitrate dehydrogenase 1/isocitrate dehydrogenase 2 (IDH1/IDH2) gene mutation IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: 3B BlackBio Dx Limited
Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: 3B BlackBio Dx Limited
Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: 3B BlackBio Dx Limited
Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: 3B BlackBio Dx Limited
Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: 3B BlackBio Dx Limited
Dengue virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: 3B BlackBio Dx Limited
Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: 3B BlackBio Biotech India Limited (a subsidiary of Kilpest India Limited)
B-cell acute lymphoblastic leukaemia (B-ALL) genetic mutation IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: 3B BlackBio Dx Limited
Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: 3B BlackBio Biotech India Limited (a subsidiary of Kilpest India Limited)
Multidrug-resistant nontuberculous Mycobacterium (NTM) nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: 3B BlackBio Dx Limited

