United Kingdom MHRA device registration 202004

Total testosterone IVD, reagent

United Kingdom·In Vitro Diagnostic Device·Chongqing iSIA BIO-Technology Co., Ltd.·Registered Nov 26, 2024

Registration details

Device ID: 202004
MHRA Reference Number: 202004
Date Registered: Nov 26, 2024
Last Updated: Oct 2, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Total testosterone IVD, reagent
Type: IVD General

Manufacturer

Name: Chongqing iSIA BIO-Technology Co., Ltd.
Address: No. 388 Jingdongfang Avenue, Beibei District,
Chongqing,, China
Created Date: Sep 27, 2024

Authorized Representative

Name: CMC Medical Devices LTD
Relationship Type: UK Responsible Person
Address: Office 32 19-21 Crawford Street
London, United Kingdom
Postcode: W1H 1PJ

Similar products

Devices with a matching generic name or device type registered with MHRA

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176179

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176185

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175386

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

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176184

C-reactive protein (CRP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176164

Cryptosporidium species antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176139

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175389

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testingN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175394

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175395

D-dimer IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176162

Other products from Chongqing iSIA BIO-Technology Co., Ltd.

Additional devices registered by the same manufacturer

Adiponectin IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 202034

Aldosterone IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 204015

Allergen-specific/total immunoglobulin E (IgE) antibody IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 203988

Alpha-fetoprotein (AFP) IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 203978

Anti-Mullerian hormone (AMH) IVD, kit, rapid ICT, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 201984

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassayNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 201968

C-peptide IVD, kit, rapid ICT, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 202008

Cancer antigen 125 (CA125) IVD, kit, fluorescent immunoassayNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 202001

Carcinoembryonic antigen (CEA) IVD, kit, fluorescent immunoassayNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 202000

25-Hydroxy vitamin D3 IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 202019

Other products from same authorized representative

Additional devices represented by CMC Medical Devices LTD in the UK

SARS-CoV-2 neutralizing antibody IVD, kit, fluorescent immunoassay, rapidNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd

Device ID: 69881

Bone curette, reusableNov 26, 2024

Type: General Medical Device

Manufacturer: CHETAN MEDITECH PVT LTD

Device ID: 198420

SARS-CoV-2 immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, rapid ICT, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd

Device ID: 69875

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassayNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd

Device ID: 69876

Hevea-latex examination/treatment glove, powderedNov 26, 2024

Type: General Medical Device

Manufacturer: Cranberry International Sdn Bhd

Device ID: 200263

SARS-CoV-2 total antibody IVD, kit, rapid ICT, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd

Device ID: 69883

Surgical/medical face mask, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Mexpo International, Inc.

Device ID: 97191

Acute myeloid leukaemia (AML) genetic mutation IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: PentaBase A/S

Device ID: 169679

Nitrile examination/treatment glove, non-powdered, non-antimicrobialNov 26, 2024

Type: General Medical Device

Manufacturer: Mexpo International, Inc.

Device ID: 97190

Bone file/rasp, manual, reusableNov 26, 2024

Type: General Medical Device

Manufacturer: CHETAN MEDITECH PVT LTD

Device ID: 198430

About this record

Total testosterone IVD, reagent is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 202004. The device is manufactured by Chongqing iSIA BIO-Technology Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is CMC Medical Devices 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 DatabasePowered by Pure Global AIMHRA RegisteredIn Vitro Diagnostic Device