United Kingdom MHRA device registration 166394

Tissue processor IVD, automated/semi-automated

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Dakewe (Shenzhen) Medical Equipment Co., Ltd. ·Registered Nov 26, 2024
Registration details
Device ID
166394
MHRA Reference Number
166394
Date Registered
Nov 26, 2024
Last Updated
Nov 29, 2023
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Tissue processor IVD, automated/semi-automated
Type
IVD General
Manufacturer
Address
Floor 5, Building B, No. 2 Luhui Road, Jinsha Community, Kengzi Street, Pingshan District
Shenzhen, China
Created Date
Feb 13, 2023
Authorized Representative
Relationship Type
UK Responsible Person
Address
3rd Floor, 70 Gracechurch Street
London, England, United Kingdom
Postcode: EC3V 0HR
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 Dakewe (Shenzhen) Medical Equipment Co., Ltd.

Additional devices registered by the same manufacturer

Other products from same authorized representative

Additional devices represented by SUNGO Certification Company Limited in the UK

Chemiluminescent immunoassay analyser IVDNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Shenzhen Watmind Medical Co., Ltd
Device ID: 163538
Creatine?kinase?myocardial?isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassayNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Shenzhen Watmind Medical Co., Ltd
Device ID: 163524
Thermal cycler nucleic acid amplification analyser IVD, laboratoryNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: RocGene (Xuzhou) Technology Limited
Device ID: 174160
Adenovirus immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinicalNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Shenzhen Watmind Medical Co., Ltd
Device ID: 164910
Evacuated blood collection tube IVD, clot activatorNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Shenyang Bokan Biotechnology Co., Ltd.
Device ID: 112256
Evacuated blood collection tube IVD, anticoagulantNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Shenyang Bokan Biotechnology Co., Ltd.
Device ID: 112260
Laboratory instrument/analyser application software IVDNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: RocGene (Xuzhou) Technology Limited
Device ID: 167445
SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinicalNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Device ID: 95095
Monkeypox virus antigen IVD, kit, rapid ICT, clinicalNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Nanjing Okay Biotechnology Co., Ltd
Device ID: 161896
Influenza A/B virus antigen IVD, kit, rapid ICT, clinicalNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Shenzhen Watmind Medical Co., Ltd
Device ID: 163518
About this record

Tissue processor IVD, automated/semi-automated is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 166394. The device is manufactured by Dakewe (Shenzhen) Medical Equipment 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 DatabasePowered by Pure Global AIMHRA RegisteredIn Vitro Diagnostic Device