Nucleic acid extraction/isolation kit IVD - UK MHRA Medical Device Registration
Nucleic acid extraction/isolation kit IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 122387. The device is manufactured by Kangmei Tianhong Biotech (Beijing) 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
Nucleic acid extraction/isolation kit IVD
Type
IVD General
Date Registered
Nov 26, 2024
Last Updated
Oct 17, 2023
Address
#16, No.1 Gaolizhang Road,
Haidian, Beijing, China
Created Date
Dec 16, 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.
SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
SARS-CoV-2/influenza A/B nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
General specimen container IVD, no additive/medium
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
SARS-CoV-2/influenza A/B antigen IVD, kit, immunochromatographic test (ICT), rapid
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Angiography kit
Type: General Medical Device
Manufacturer: Shenzhen Boon Medical Supply Co., Ltd.
Anaesthesia depth monitor
Type: General Medical Device
Manufacturer: Shenzhen Delica Medical Equipment Co., Ltd.
Cerebral oximeter
Type: General Medical Device
Manufacturer: Shenzhen Delica Medical Equipment Co., Ltd.
Electroencephalograph
Type: General Medical Device
Manufacturer: Shenzhen Delica Medical Equipment Co., Ltd.
Infrared patient thermometer, skin
Type: General Medical Device
Manufacturer: Shenzhen Finicare Co., Ltd.
Infrared patient thermometer, skin
Type: General Medical Device
Manufacturer: Shenzhen Pacom Medical Instruments Co., Ltd.
Analgesic transcutaneous electrical nerve stimulation system
Type: General Medical Device
Manufacturer: Shenzhen Roundwhale Technology Co., Ltd.
Rotary/reciprocating endodontic file/rasp, reusable
Type: General Medical Device
Manufacturer: Shenzhen Rogin Medical Co., Ltd.
Extracorporeal ultrasound imaging transducer, hand-held
Type: General Medical Device
Manufacturer: Shenzhen Sonosray Technology Co., Ltd.
Infrared patient thermometer, ear/skin
Type: General Medical Device
Manufacturer: Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.

