United Kingdom MHRA device registration 205430

Methylated DNA IVD, kit, nucleic acid technique (NAT)

United Kingdom·In Vitro Diagnostic Device·Beijing OriginPoly Bio-Tec Co., Ltd.·Registered Nov 26, 2024

Registration details

Device ID: 205430
MHRA Reference Number: 205430
Date Registered: Nov 26, 2024
Last Updated: Nov 21, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Methylated DNA IVD, kit, nucleic acid technique (NAT)
Type: IVD General

Manufacturer

Name: Beijing OriginPoly Bio-Tec Co., Ltd.
Address: Room 401,No.6 Building & 3rd Floor, No.18 Building, Yard 50, Huatuo Road, Daxing Biomedical Industry Base, Zhongguancun Science and Technology Park, Daxing District
Beijing, China
Created Date: Nov 19, 2024

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

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 Beijing OriginPoly Bio-Tec Co., Ltd.

Additional devices registered by the same manufacturer

Nucleic acid extraction/isolation kit IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 205433

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

Type: In Vitro Diagnostic Device

Device ID: 205429

Multiple-type vaginitis-associated organism nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 205432

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

Type: In Vitro Diagnostic Device

Device ID: 205431

Nucleic acid extraction/isolation kit IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 205434

Nucleic acid extraction/isolation kit IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 205435

Nucleic acid extraction/isolation kit IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 205436

Other products from same authorized representative

Additional devices represented by SUNGO Certification Company Limited in the UK

Cotton wool ball, sterileNov 26, 2024

Type: General Medical Device

Manufacturer: Kingstar Medical (Xianning) Co., Ltd

Device ID: 130619

First aid absorbent pad/bandageNov 26, 2024

Type: General Medical Device

Manufacturer: Kingstar Medical (Xianning) Co., Ltd

Device ID: 154507

Radiopaque woven surgical spongeNov 26, 2024

Type: General Medical Device

Manufacturer: Kingstar Medical (Xianning) Co., Ltd

Device ID: 101931

Skin-cleaning wipe, non-sterileNov 26, 2024

Type: General Medical Device

Manufacturer: Kingstar Medical (Xianning) Co., Ltd

Device ID: 130616

Isolation gown, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Rizhao Sanqi Medical & Health Articles Co., Ltd.

Device ID: 135646

Surgical cap, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Rizhao Sanqi Medical & Health Articles Co., Ltd.

Device ID: 137842

Surgical/medical face mask, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Rizhao Sanqi Medical & Health Articles Co., Ltd.

Device ID: 135645

Burn gelNov 26, 2024

Type: General Medical Device

Manufacturer: Roosin Medical Co., Ltd.

Device ID: 69061

Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialNov 26, 2024

Type: General Medical Device

Manufacturer: Roosin Medical Co., Ltd.

Device ID: 69059

Adhesive bandageNov 26, 2024

Type: General Medical Device

Manufacturer: Kingstar Medical (Xianning) Co., Ltd

Device ID: 154509

About this record

Methylated DNA IVD, kit, nucleic acid technique (NAT) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 205430. The device is manufactured by Beijing OriginPoly Bio-Tec 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