United Kingdom MHRA device registration 161896

Monkeypox virus antigen IVD, kit, rapid ICT, clinical

United Kingdom·In Vitro Diagnostic Device·Nanjing Okay Biotechnology Co., Ltd·Registered Nov 26, 2024

Registration details

Device ID: 161896
MHRA Reference Number: 161896
Date Registered: Nov 26, 2024
Last Updated: Nov 15, 2023

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Monkeypox virus antigen IVD, kit, rapid ICT, clinical
Type: IVD General

Manufacturer

Name: Nanjing Okay Biotechnology Co., Ltd
Address: No. 11 Puwu North Road, Nanjing
Jiangsu Province, China
Created Date: Nov 28, 2022

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 same authorized representative

Additional devices represented by SUNGO Certification Company Limited in the UK

Indwelling urethral drainage balloon catheter, non-antimicrobialNov 26, 2024

Type: General Medical Device

Manufacturer: NANCHANG YILI MEDICAL INSTRUMENT CO., LTD

Device ID: 178530

Surgical cap, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Sanqi (Vietnam) New Materials Co., Ltd.

Device ID: 161672

Silicone dental impression materialNov 26, 2024

Type: General Medical Device

Manufacturer: Nanchang Dental Bright Technology Co., Ltd.

Device ID: 70390

Basic endotracheal tube, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: NANCHANG YILI MEDICAL INSTRUMENT CO., LTD

Device ID: 176884

Steam sterilizerNov 26, 2024

Type: General Medical Device

Manufacturer: Ningbo Mingtai Medical Instrument Co., ltd

Device ID: 195482

Non-wearable adult urine collection bag, open-endedNov 26, 2024

Type: General Medical Device

Manufacturer: NANCHANG YILI MEDICAL INSTRUMENT CO., LTD

Device ID: 178528

Monkeypox virus nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: BioTeke Corporation (Wuxi) Co., Ltd

Device ID: 154026

Dental impression tray, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Nanchang Dental Bright Technology Co., Ltd.

Device ID: 70389

Airway suction catheterNov 26, 2024

Type: General Medical Device

Manufacturer: NANCHANG YILI MEDICAL INSTRUMENT CO., LTD

Device ID: 176887

Surgical cap, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Shandong GD Technology Co., Ltd

Device ID: 161337

About this record

Monkeypox virus antigen IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 161896. The device is manufactured by Nanjing Okay Biotechnology 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