General specimen container IVD, no additive/medium - UK MHRA Medical Device Registration
General specimen container IVD, no additive/medium is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 171254. 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.
Device Type
In Vitro Diagnostic Device
Devices
General specimen container IVD, no additive/medium
Type
Class A
Date Registered
Nov 26, 2024
Last Updated
Jun 22, 2024
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
Relationship Type
Address
Beaver House, 23-38 Hythe Bridge Street
Oxford, England, United Kingdom
Postcode: OX1 2EP
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.
Ferritin IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Registered: Mar 6, 2025
Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Mar 6, 2025
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control
Type: In Vitro Diagnostic Device
Registered: Mar 6, 2025
Troponin T IVD, control
Type: In Vitro Diagnostic Device
Registered: Mar 6, 2025
Troponin I IVD, control
Type: In Vitro Diagnostic Device
Registered: Mar 6, 2025
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, rapid colorimetric, clinical
Type: In Vitro Diagnostic Device
Registered: Mar 6, 2025
Haemoglobin/glucose-6-phosphate dehydrogenase (G6PD) analyser IVD
Type: In Vitro Diagnostic Device
Registered: Mar 6, 2025
Troponin I IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Registered: Mar 6, 2025
Troponin T IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Registered: Mar 6, 2025
Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Feb 14, 2025
Laparoscopic motorized instrument control unit
Type: General Medical Device
Manufacturer: American Orthodontics Corp
Electrochemical breath analyser IVD, point-of-care
Type: In Vitro Diagnostic Device
Manufacturer: Bosch Healthcare Solutions GmbH
Cartridge-accepting autoinjector, mechanical
Type: General Medical Device
Manufacturer: Shire Pharmaceuticals Ireland Limited
Blood gas syringe/needle, lithium heparin
Type: General Medical Device
Manufacturer: SunMed LLC.
Automated ophthalmic refractometer
Type: General Medical Device
Manufacturer: Forus Health Pvt. Ltd.
Ophthalmic fundus camera
Type: General Medical Device
Manufacturer: Forus Health Pvt. Ltd.
Multiple Bordetella species nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Bosch Healthcare Solutions GmbH
External limb prosthesis socket liner
Type: General Medical Device
Manufacturer: Swiss Motion Technologies SA
Coagulation factor VIII IVD, kit, chromogenic
Type: In Vitro Diagnostic Device
Manufacturer: Immucor GTI Diagnostics, Inc.
Electrochemical breath analyser IVD, home-use
Type: In Vitro Diagnostic Device
Manufacturer: Bosch Healthcare Solutions GmbH

