SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration
SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 100953. The device is manufactured by Feng Chun Yuan Medical Equipment (Shenzhen) 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
SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical
Type
IVD General
Date Registered
Nov 26, 2024
Last Updated
May 9, 2024
Address
Room 1304 & Room 504, No.48, Xinyu Road, Xiangshan Community, Xinqiao Street, Baoan District,
Shenzhen, Guangdong, China
Created Date
Aug 30, 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.
Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Type: General Medical Device
Manufacturer: Careglove Global SDN BHD
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Type: General Medical Device
Manufacturer: Careplus (M) Sdn Bhd
Dental cotton roll
Type: General Medical Device
Manufacturer: CDM Center of Excellence Ltd.
Endodontic instrument chairside holder set
Type: General Medical Device
Manufacturer: CDM Center of Excellence Ltd.
Hypodermic needle, single-use
Type: General Medical Device
Manufacturer: CDM Center of Excellence Ltd.
Dappen dish, single-use
Type: General Medical Device
Manufacturer: CDM Center of Excellence Ltd.
Dental anaesthesia syringe/needle
Type: General Medical Device
Manufacturer: CDM Center of Excellence Ltd.
Dental cotton roll
Type: General Medical Device
Manufacturer: CDM Center of Excellence Ltd.
Dental material application tool, single-use
Type: General Medical Device
Manufacturer: CDM Center of Excellence Ltd.
Hevea-latex examination/treatment glove, powdered
Type: General Medical Device
Manufacturer: Careglove Global SDN BHD

