United Kingdom MHRA device registration 205431
Methylated DNA IVD, kit, nucleic acid technique (NAT)
United Kingdom·In Vitro Diagnostic Device·Beijing OriginPoly Bio-Tec Co., Ltd.·Registered Nov 26, 2024Registration details
- Device ID
- 205431
- MHRA Reference Number
- 205431
- 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
- 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
- Relationship Type
- UK Responsible Person
- Address
- 3rd Floor, 70 Gracechurch Street London, England, United KingdomPostcode: 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
Methylated DNA IVD, kit, nucleic acid technique (NAT)Nov 26, 2024
Type: In Vitro Diagnostic Device
Device ID: 205430
Multiple-type vaginitis-associated organism nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024
Type: In Vitro Diagnostic Device
Device ID: 205432
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
Basic endotracheal tube, single-useNov 26, 2024
Type: General Medical Device
Manufacturer: Guangdong Ecan Medical Co., Ltd
Device ID: 176439
Nasogastric feeding tubeNov 26, 2024
Type: General Medical Device
Manufacturer: Guangdong Ecan Medical Co., Ltd
Device ID: 104488
Nebulizing system delivery set, single-useNov 26, 2024
Type: General Medical Device
Manufacturer: Guangdong Ecan Medical Co., Ltd
Device ID: 176438
Non-wearable adult urine collection bag, open-endedNov 26, 2024
Type: General Medical Device
Manufacturer: Guangdong Ecan Medical Co., Ltd
Device ID: 104495
Oropharyngeal airway, single-useNov 26, 2024
Type: General Medical Device
Manufacturer: Guangdong Ecan Medical Co., Ltd
Device ID: 104493
Alternating-pressure chair cushion, reusableNov 26, 2024
Type: General Medical Device
Manufacturer: Guangdong Yuehua Medical Instrument Factory Co., Ltd.
Device ID: 157824
Disposable surgical irrigation/aspiration systemNov 26, 2024
Type: General Medical Device
Manufacturer: Guangzhou Clean Medical Products Manufacturing Corp.
Device ID: 86137
Endoscopic video image display unitNov 26, 2024
Type: General Medical Device
Manufacturer: Guangzhou Red Pine Medical Instrument Co., Ltd.
Device ID: 111892
Endoscopic video image display unitNov 26, 2024
Type: General Medical Device
Manufacturer: Guangzhou Red Pine Medical Instrument Co., Ltd.
Device ID: 183345
Nitrile examination/treatment glove, non-powdered, non-antimicrobialNov 26, 2024
Type: General Medical Device
Manufacturer: Grand Work Plastic Products Co., Ltd.
Device ID: 158835
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 205431. 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