Mycoplasma pneumoniae total antibody IVD, kit, fluorescent immunoassay - UK MHRA Medical Device Registration

Mycoplasma pneumoniae total antibody IVD, kit, fluorescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 155660. The device is manufactured by SD Biosensor, Inc. from South Korea, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MT Promedt Consulting 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

🇬🇧

Mycoplasma pneumoniae total antibody IVD, kit, fluorescent immunoassay

MHRA Device ID: 155660•Ref: 155660

Device Type

In Vitro Diagnostic Device

Devices

Mycoplasma pneumoniae total antibody IVD, kit, fluorescent immunoassay

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Jun 22, 2024

Manufacturer Information

Name

SD Biosensor, Inc.

Address

C-4th&5th, 16 Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do 16690, Republic of Korea

Suwon-si, South Korea

Created Date

May 11, 2021

Authorized Representative

Name

MT Promedt Consulting Ltd

Relationship Type

UK Responsible Person

Address

Beaver House, 23-38 Hythe Bridge Street

Oxford, England, United Kingdom

Postcode: OX1 2EP

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from SD Biosensor, Inc. (10)

Other Products from Same Authorized Representative (10)

Mycoplasma pneumoniae total antibody IVD, kit, fluorescent immunoassay - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay

Cryptosporidium species antigen IVD, kit, rapid ICT, clinical

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

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

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical

D-dimer IVD, kit, fluorescent immunoassay

Ferritin IVD, kit, fluorescent immunoassay

Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control

Troponin T IVD, control

Troponin I IVD, control

Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, rapid colorimetric, clinical

Haemoglobin/glucose-6-phosphate dehydrogenase (G6PD) analyser IVD

Troponin I IVD, kit, fluorescent immunoassay

Troponin T IVD, kit, fluorescent immunoassay

Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical

Laparoscopic motorized instrument control unit

Catheter injection port

CT contrast medium injection system, battery-powered

Vial/bottle adaptor, non-hermetic

Contrast medium injection system control unit

Contrast medium injection system control unit

Luer/Luer linear connector, single-use

CT contrast medium injection system, line-powered, stationary

Infrared patient thermometer, ear/skin

Shoulder/elbow/wrist/hand orthosis