Sperm concentration indicator IVD, kit, rapid colorimetric, self-testing - UK MHRA Medical Device Registration

Sperm concentration indicator IVD, kit, rapid colorimetric, self-testing is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 101453. The device is manufactured by PRIMA Lab SA from Switzerland, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Qarad 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

🇬🇧

Sperm concentration indicator IVD, kit, rapid colorimetric, self-testing

MHRA Device ID: 101453•Ref: 101453

Device Type

In Vitro Diagnostic Device

Devices

Sperm concentration indicator IVD, kit, rapid colorimetric, self-testing

Type

IVD Devices for Self-Testing

Date Registered

Nov 26, 2024

Last Updated

May 22, 2024

Manufacturer Information

Name

PRIMA Lab SA

Address

Via Antonio Monti Balerna

Balerna, Mendrisio, Switzerland

Created Date

Jul 9, 2021

Authorized Representative

Name

Qarad UK Ltd.

Relationship Type

UK Responsible Person

Address

8 Northumberland Ave

Westminster, London , England, United Kingdom

Postcode: WC2N 5BY

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from PRIMA Lab SA (10)

Other Products from Same Authorized Representative (10)

Sperm concentration indicator IVD, kit, rapid colorimetric, self-testing - 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

Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing

Faecal occult blood IVD, kit, rapid ICT, clinical

Multiple form 25-hydroxy vitamin D IVD, kit, rapid ICT, clinical

Total cholesterol lipid IVD, kit, rapid colorimetric, self-testing

Total prostate specific antigen (tPSA) IVD, kit, rapid ICT, self-testing

Helicobacter pylori antigen IVD, kit, rapid ICT, self-testing

Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, rapid ICT, self-testing

Amniotic fluid leak detection device IVD

C-reactive protein (CRP) IVD, kit, rapid ICT, clinical

Anti-B red blood cell grouping IVD, antibody

Anti-Jk^a red blood cell grouping IVD, antibody

Anti-E [RH005] red blood cell grouping IVD, antibody

Acrylic resin embedding kit IVD

Anti-C^w red blood cell grouping IVD, antibody

Anti-Fy^a red blood cell grouping IVD, antibody

Amyloid B component IVD, control

Tau protein IVD, kit, enzyme immunoassay (EIA)

ABO/Rh multiple blood grouping IVD, kit, agglutination

Anti-Le^a red blood cell grouping IVD, antibody