Thermal cycler nucleic acid amplification analyser IVD, laboratory - UK MHRA Medical Device Registration

Thermal cycler nucleic acid amplification analyser IVD, laboratory is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 153250. The device is manufactured by 3D Biomedicine Science & Technology Co., Ltd from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is NPZ technology 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

🇬🇧

Thermal cycler nucleic acid amplification analyser IVD, laboratory

MHRA Device ID: 153250•Ref: 153250

Device Type

In Vitro Diagnostic Device

Devices

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Type

Class A

Date Registered

Nov 26, 2024

Last Updated

Sep 26, 2024

Manufacturer Information

Name

3D Biomedicine Science & Technology Co., Ltd

Address

Block A, Building 2, No. 158 Xinjunhuan Rd

Shanghai, China

Created Date

Dec 8, 2021

Authorized Representative

Name

NPZ technology Ltd

Relationship Type

UK Responsible Person

Address

Stirling House Cambridge Innovation Park, Denny End Road, Waterbeach

Cambridge, Cambridgeshire, United Kingdom

Postcode: CB25 9QE

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from 3D Biomedicine Science & Technology Co., Ltd (6)

Other Products from Same Authorized Representative (10)

Thermal cycler nucleic acid amplification analyser IVD, laboratory - 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

Cancer-related multiple gene mutation profile kit IVD

BRCA1/BRCA2 genotyping IVD, kit, nucleic acid sequencing technique

Nucleic acid extraction/isolation kit IVD

Nucleic acid sample preparation instrument IVD

Human genomic analysis interpretive software IVD

Pipetting system IVD

Flexible endoscopic biopsy forceps, single-use

Oesophageal bougie, single-use

First aid absorbent pad/bandage

Skin-cover adhesive strip, non-antimicrobial

Synthetic polymer semi-permeable film dressing, adhesive

Dental digital imaging sensor, intraoral

Dental power tool system handpiece, battery-powered

Dental surgical power tool motorized handpiece/set, electric

Dental/surgical polymerization lamp

Endoscopic bite block, basic, single-use