Influenza B virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration
Influenza B virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 137255. The device is manufactured by NeoMedica doo from Serbia, 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
Influenza B virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Type
IVD General
Date Registered
Apr 11, 2024
Last Updated
Oct 17, 2023
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.
Aldosterone IVD, calibrator
Type: In Vitro Diagnostic Device
Registered: Apr 11, 2024
Aldosterone IVD, control
Type: In Vitro Diagnostic Device
Registered: Apr 11, 2024
Aldosterone IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Apr 11, 2024
Allergen-specific immunoglobulin E (IgE) antibody IVD, control
Type: In Vitro Diagnostic Device
Registered: Apr 11, 2024
Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Apr 11, 2024
Alpha-fetoprotein (AFP) IVD, control
Type: In Vitro Diagnostic Device
Registered: Apr 11, 2024
Anti-Mullerian hormone (AMH) IVD, control
Type: In Vitro Diagnostic Device
Registered: Apr 11, 2024
Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Apr 11, 2024
Borrelia afzelii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Apr 11, 2024
17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Apr 11, 2024
Breathing circuit bag, single-use
Type: General Medical Device
Manufacturer: Omnimate Enterprise Co., Ltd.
Fixed examination/treatment room light
Type: General Medical Device
Manufacturer: Burton Medical LLC
Surgical/medical face mask, single-use
Type: General Medical Device
Manufacturer: BYD Precision Manufacture Co., Ltd.
Mobile/portable oxygen concentrator
Type: General Medical Device
Manufacturer: Oxytek Medical Technology Co., Ltd.
Wheelchair, electric-motor-driven, occupant-controlled, manual-steering, non-collapsible
Type: General Medical Device
Manufacturer: PARAVAN GmbH
Operating table torso positioner
Type: General Medical Device
Manufacturer: Opitek International
Cervicothoracic spine orthosis
Type: General Medical Device
Manufacturer: OPTEC USA Inc
Hip orthosis
Type: General Medical Device
Manufacturer: OPTEC USA Inc
Penile vacuum device
Type: General Medical Device
Manufacturer: BonRoux Pty Ltd
Anaesthesia face mask, reusable
Type: General Medical Device
Manufacturer: Omnimate Enterprise Co., Ltd.

