United Kingdom MHRA device registration 114444

Nucleic acid extraction/isolation kit IVD

United Kingdom·In Vitro Diagnostic Device·ENVELOPE HEALTH BIOTECHNOLOGY CO., LTD.·Registered Nov 26, 2024

Registration details

Device ID: 114444
MHRA Reference Number: 114444
Date Registered: Nov 26, 2024
Last Updated: Aug 14, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Nucleic acid extraction/isolation kit IVD
Type: IVD General

Manufacturer

Name: ENVELOPE HEALTH BIOTECHNOLOGY CO., LTD.
Address: 1203, No. 7 Building, South Mingzhu apartment, No. 21 Hongan 3 Street, Donghai community, Yantian Street, Yantian District,
Shenzhen, China
Created Date: Oct 11, 2021

Authorized Representative

Name: MedPath Limited
Relationship Type: UK Responsible Person
Address: 27 Old Gloucester Street
London, England, United Kingdom
Postcode: WC1N 3AX

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 ENVELOPE HEALTH BIOTECHNOLOGY CO., LTD.

Additional devices registered by the same manufacturer

Faecal specimen collection kit IVD, home-useNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 107686

Methylated DNA IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 107687

Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 107688

Other products from same authorized representative

Additional devices represented by MedPath Limited in the UK

Airway suction catheterNov 26, 2024

Type: General Medical Device

Manufacturer: Haiyan Kangyuan Medical Instrument Co., Ltd.

Device ID: 185333

Basic endotracheal tube, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Haiyan Kangyuan Medical Instrument Co., Ltd.

Device ID: 70499

Basic endotracheal tube, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Haiyan Kangyuan Medical Instrument Co., Ltd.

Device ID: 185330

Gastrostomy aspiration system stomach tubeNov 26, 2024

Type: General Medical Device

Manufacturer: Haiyan Kangyuan Medical Instrument Co., Ltd.

Device ID: 70504

Laryngeal mask airway, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Haiyan Kangyuan Medical Instrument Co., Ltd.

Device ID: 185334

Reinforced endotracheal tube, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Haiyan Kangyuan Medical Instrument Co., Ltd.

Device ID: 185332

Reinforced laryngeal mask airway, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Haiyan Kangyuan Medical Instrument Co., Ltd.

Device ID: 70503

Reinforced laryngeal mask airway, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Haiyan Kangyuan Medical Instrument Co., Ltd.

Device ID: 185335

Polymeric ureteral stentNov 26, 2024

Type: General Medical Device

Manufacturer: Hunan Reborn Medical Science and Technology Development Co., Ltd

Device ID: 183999

Peripheral angioplasty balloon catheter, basicNov 26, 2024

Type: General Medical Device

Manufacturer: Hangzhou Barty Medical Equipment Co., Ltd.

Device ID: 173540

About this record

Nucleic acid extraction/isolation kit IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 114444. The device is manufactured by ENVELOPE HEALTH BIOTECHNOLOGY CO., LTD. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MedPath 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