Rotavirus antigen IVD, reagent - UK MHRA Medical Device Registration

Rotavirus antigen IVD, reagent is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 176541. The device is manufactured by Boditech Med Inc. from South Korea, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Obelis UK 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.

Free Database

MHRA Registered

In Vitro Diagnostic Device

🇬🇧

Rotavirus antigen IVD, reagent

MHRA Device ID: 176541•Ref: 176541

Device Type

In Vitro Diagnostic Device

Devices

Rotavirus antigen IVD, reagent

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Mar 20, 2024

Manufacturer Information

Name

Boditech Med Inc.

Address

43, Geodudanji 1-gil, Dongnae-myeon, Chuncheon-si, Gang-won-do 24398, Republic of Korea

Chuncheon-si, South Korea

Created Date

Mar 22, 2023

Authorized Representative

Name

Obelis UK Ltd

Relationship Type

UK Responsible Person

Address

Sandford Gate, East Point Business Park

Oxford , England, United Kingdom

Postcode: OX4 6LB

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Boditech Med Inc. (10)

Other Products from Same Authorized Representative (10)

Rotavirus antigen IVD, reagent - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Clostridium difficile antigen IVD, antibody

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Prolactin IVD, kit, fluorescent immunoassay

Troponin I IVD, kit, fluorescent immunoassay

Interleukin-6 (IL-6) IVD, kit, rapid ICT, clinical

Multiple Salmonella species immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Rotavirus antigen IVD, kit, rapid ICT, clinical

Total cortisol IVD, reagent

Creatine kinase myocardial isoenzyme (CKMB) IVD, control

Fluorescent immunoassay analyser IVD, point-of-care

D-dimer IVD, kit, fluorescent immunoassay

Ferritin IVD, control

Ferritin IVD, kit, fluorescent immunoassay

Cyclic citrullinated peptide antibody (anti-CCP) IVD, control

Free thyroxine (FT4) IVD, kit, fluorescent immunoassay

Human chorionic gonadotropin beta-subunit (beta-HCG)/follicle stimulating hormone (FSH) IVD, control

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

Total cortisol IVD, reagent

Prothrombin time (PT) IVD, reagent

Negative-pressure wound therapy system pump, electric

Enteral feeding noninvasive-component set

Enteral feeding noninvasive-component set

Nasogastric feeding tube

Total thyroxine (TT4) IVD, kit, fluorescent immunoassay

ENFit/Luer linear connector

Total triiodothyronine (TT3) IVD, control

Alternating-pressure chair cushion, reusable