Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration
Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, kit, nucleic acid technique (NAT) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 148434. The device is manufactured by 3B BlackBio Biotech India Limited (a subsidiary of Kilpest India Limited) from India, 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
Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, kit, nucleic acid technique (NAT)
Type
IVD General
Date Registered
Nov 26, 2024
Last Updated
Feb 9, 2024
Address
7-C, Industrial Area Govindpura Bhopal
Bhopal, India
Created Date
May 13, 2022
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.
Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Dihydropyrimidine dehydrogenase (DPYD) gene polymorphism IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Multiple immunocompromised host infection-associated virus nucleic acid IVD, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Nucleic acid extraction/isolation kit IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Thiopurine S-methyltransferase (TPMT) gene polymorphism IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Leukaemia-associated fusion gene IVD, control
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Leukaemia-associated fusion gene IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Non-ISO80369-standardized small-bore linear connector, reusable
Type: General Medical Device
Manufacturer: Wuxi Jike Electronics Co., Ltd.
Non-ISO80369-standardized small-bore linear connector, reusable
Type: General Medical Device
Manufacturer: Wuxi Jike Electronics Co., Ltd.
Intraoral optical scanning system
Type: General Medical Device
Manufacturer: Shenzhen Xpectvision Technology Co., Ltd.
Wound-nonadherent dressing, absorbent, non-antimicrobial
Type: General Medical Device
Manufacturer: Solaplus Biotech Co., Ltd.
Surgical/medical face mask, single-use
Type: General Medical Device
Manufacturer: Fujian Kang Chen Daily Necessities Co., Ltd.
External ocular measurement camera
Type: General Medical Device
Manufacturer: Suzhou Microclear Medical Instruments Co., Ltd.
Scanning-laser retinal imaging system
Type: General Medical Device
Manufacturer: Suzhou Microclear Medical Instruments Co., Ltd.
External ocular measurement camera
Type: General Medical Device
Manufacturer: Suzhou Microclear Medical Instrument Co., Ltd.
Ophthalmic fundus camera
Type: General Medical Device
Manufacturer: Suzhou Microclear Medical Instrument Co., Ltd.
Heated respiratory humidifier
Type: General Medical Device
Manufacturer: Wuxi Jike Electronics Co., Ltd.

