United Kingdom MHRA device registration 156593

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

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Nanjing Difei Medical Equipment Co., Ltd. ·Registered Nov 26, 2024
Registration details
Device ID
156593
MHRA Reference Number
156593
Date Registered
Nov 26, 2024
Last Updated
Oct 4, 2023
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Monkeypox virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type
IVD General
Manufacturer
Address
2nd & 8th Floor, B Block, No.128 Huakang Road, Jiangbei  New Area
Nanjing, Jiangsu, China
Created Date
Sep 23, 2022
Authorized Representative
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 same authorized representative

Additional devices represented by MedPath Limited in the UK

Adhesive bandageNov 26, 2024
Type: General Medical Device
Manufacturer: Planet (Anhui) Medical Products Co., Ltd.
Device ID: 184226
Nucleic acid extraction/isolation kit IVDNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Device ID: 159271
Prescription spectaclesNov 26, 2024
Type: General Medical Device
Manufacturer: HongKong Marvel Limited.
Device ID: 180741
Microscope slide digital imaging scanner IVDNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Ningbo My-BioMed Biotechnology Co.,Ltd.
Device ID: 112848
Stationary panoramic/tomographic dental x-ray system, digitalNov 26, 2024
Type: General Medical Device
Manufacturer: Hefei Meyer Optoelectronic Technology Inc.
Device ID: 180037
Nitrile examination/treatment glove, non-powdered, non-antimicrobialNov 26, 2024
Type: General Medical Device
Manufacturer: Hengchang (Dongying) Medical Technology Co., Ltd.
Device ID: 81208
Cast/bandage waterproof bathing cover, single-useNov 26, 2024
Type: General Medical Device
Manufacturer: Guangzhou Nuoning Medical Supplies Co., Ltd
Device ID: 203380
Snake/insect venom suction deviceNov 26, 2024
Type: General Medical Device
Manufacturer: Guangzhou Nuoning Medical Supplies Co., Ltd
Device ID: 203379
Intraoral optical scanning systemNov 26, 2024
Type: General Medical Device
Manufacturer: Hefei Meyer Optoelectronic Technology Inc.
Device ID: 180038
Monkeypox virus antigen IVD, kit, rapid ICT, clinicalNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Guangdong Wesail Biotech Co., Ltd.
Device ID: 156234
About this record

Monkeypox virus nucleic acid 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 156593. The device is manufactured by Nanjing Difei Medical Equipment 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