Nucleic acid sample preparation instrument IVD, semi-automated - UK MHRA Medical Device Registration

Nucleic acid sample preparation instrument IVD, semi-automated is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 132968. The device is manufactured by Hangzhou Bioer Technology Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is SUNGO Certification Company Limited.

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

🇬🇧

Nucleic acid sample preparation instrument IVD, semi-automated

MHRA Device ID: 132968•Ref: 132968

Device Type

In Vitro Diagnostic Device

Devices

Nucleic acid sample preparation instrument IVD, semi-automated

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Aug 15, 2024

Manufacturer Information

Name

Hangzhou Bioer Technology Co., Ltd.

Address

1192 BinAn Rd, Binjiang District, Hangzhou

Zhejiang Province, China

Created Date

Nov 10, 2021

Authorized Representative

Name

SUNGO Certification Company Limited

Relationship Type

UK Responsible Person

Address

3rd Floor, 70 Gracechurch Street

London, England, United Kingdom

Postcode: EC3V 0HR

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Hangzhou Bioer Technology Co., Ltd. (4)

Other Products from Same Authorized Representative (10)

Nucleic acid sample preparation instrument IVD, semi-automated - 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

Monkeypox virus nucleic acid IVD, kit, nucleic acid technique (NAT)

General specimen container IVD, additive/medium

Nucleic acid extraction/isolation kit IVD

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Evacuated blood collection tube IVD, anticoagulant/separator

Evacuated blood collection tube IVD, antiglycolytic

Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay

Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay

Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay

Interleukin-6 (IL-6) IVD, kit, chemiluminescent immunoassay

Lipoprotein-associated phospholipase A2 (Lp-PLA2) IVD, kit, chemiluminescent immunoassay

Monkeypox virus antigen IVD, kit, rapid ICT, clinical

Multiple gastrointestinal virus antigen IVD, kit, rapid ICT, clinical

Monkeypox virus immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical