Prothrombin time (PT) IVD, reagent - UK MHRA Medical Device Registration
Prothrombin time (PT) IVD, reagent is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 154596. The device is manufactured by Universal Biosensors Pty Ltd from Australia, 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.
Device Type
In Vitro Diagnostic Device
Devices
Prothrombin time (PT) IVD, reagent
Type
IVD General
Date Registered
Aug 18, 2022
Last Updated
Jan 23, 2024
Address
1 Corporate Avenue
Rowville, Victoria, Australia
Created Date
Aug 18, 2022
Name
Obelis UK LtdRelationship Type
Address
Sandford Gate, East Point Business Park
Oxford , England, United Kingdom
Postcode: OX4 6LB
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.
Prothrombin time (PT) IVD, reagent
Type: In Vitro Diagnostic Device
Prothrombin time (PT) IVD, reagent
Type: In Vitro Diagnostic Device
Registered: Jul 6, 2024
Prothrombin time (PT) IVD, control
Type: In Vitro Diagnostic Device
Registered: Jun 13, 2024
Coagulation analyser IVD, point-of-care, battery-powered
Type: In Vitro Diagnostic Device
Registered: Jun 13, 2024
Coagulation analyser IVD, point-of-care, battery-powered
Type: In Vitro Diagnostic Device
Registered: Feb 23, 2024
Prothrombin time (PT) IVD, control
Type: In Vitro Diagnostic Device
Registered: Aug 18, 2022
Coagulation analyser IVD, point-of-care, battery-powered
Type: In Vitro Diagnostic Device
Registered: Aug 18, 2022
Total cortisol IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: Boditech Med Inc.
Prothrombin time (PT) IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: Universal Biosensors Pty Ltd
Haemodialysis system dialyser holder
Type: General Medical Device
Manufacturer: SHAOXING YIBON MEDICAL CO., LTD.
Eye lubricant
Type: General Medical Device
Manufacturer: Sentiss Pharma Private Limited
Cotton wool ball
Type: General Medical Device
Manufacturer: SHAOXING YIBON MEDICAL CO., LTD.
General-purpose bowl, single-use
Type: General Medical Device
Manufacturer: SHAOXING YIBON MEDICAL CO., LTD.
Adhesive bandage
Type: General Medical Device
Manufacturer: SHAOXING YIBON MEDICAL CO., LTD.
Atomizer, non-ventilatory
Type: General Medical Device
Manufacturer: Jiangsu Yuyue Medical Equipment & Supply Co. Ltd
Intraocular telescope
Type: General Medical Device
Manufacturer: Samsara Vision Ltd.
Medicine cup, single-use
Type: General Medical Device
Manufacturer: SHAOXING YIBON MEDICAL CO., LTD.

