Full blood count IVD, calibrator - UK MHRA Medical Device Registration
Full blood count IVD, calibrator is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 112671. 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
Full blood count IVD, calibrator
Type
IVD General
Date Registered
Nov 26, 2024
Last Updated
Feb 9, 2024
Address
No.D-07 Information Industry District, High-Tech Zone,
Guilin, Guangxi, China
Created Date
Feb 3, 2021
Name
Wellkang LtdRelationship Type
Address
Enterprise Hub, NW Business Complex 1 Beraghmore Road
Derry, Northern Ireland, Northern Ireland, United Kingdom
Postcode: BT48 8SE
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
Urine analyser IVD, laboratory
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Dental/surgical polymerization lamp
Type: General Medical 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
Electrocardiographic electrode, single-use
Type: General Medical Device
Manufacturer: Dongguan Quanding Medical Supplies Co., Ltd.
Cytology specimen container IVD, transport buffer
Type: In Vitro Diagnostic Device
Manufacturer: Heng Rong (Xiamen) Plastic Products Co., Ltd.
Interferon gamma release IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: Hainan VTI Clinical Immunology Lab Ltd.
SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Kangmei Tianhong Biotech (Beijing) Co., Ltd.
SARS-CoV-2/influenza A/B nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Kangmei Tianhong Biotech (Beijing) Co., Ltd.
Carcinoembryonic antigen (CEA) IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: LGC Clinical Diagnostics, Inc.
D-dimer IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: LGC Clinical Diagnostics, Inc.
Glycated haemoglobin (HbA1c) IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: LGC Clinical Diagnostics, Inc.
Multiple anticonvulsant therapeutic drug monitoring IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: LGC Clinical Diagnostics, Inc.
Surgical/medical face mask, single-use
Type: General Medical Device
Manufacturer: Dongguan Quanding Medical Supplies Co., Ltd.

