Laboratory instrument/analyser application software IVD - UK MHRA Medical Device Registration
Laboratory instrument/analyser application software IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 167445. The device is manufactured by RocGene (Xuzhou) Technology Limited 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.
Device Type
In Vitro Diagnostic Device
Devices
Laboratory instrument/analyser application software IVD
Type
IVD General
Date Registered
Nov 26, 2024
Last Updated
Dec 21, 2023
Address
Second Floor, Phase 1, Building 6, No. 10 Zhujiang East Road Third Industrial Park, Xuzhou High-tech Industrial Development Zone
Jiangsu Province, China
Created Date
Feb 28, 2023
Relationship Type
Address
3rd Floor, 70 Gracechurch Street
London, England, United Kingdom
Postcode: EC3V 0HR
Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
C-reactive protein (CRP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Cryptosporidium species antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
D-dimer IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Type: General Medical Device
Manufacturer: Roosin Medical Co., Ltd.
Exudate-absorbent dressing, non-gel, non-antimicrobial
Type: General Medical Device
Manufacturer: Roosin Medical Co., Ltd.
Scrub suit, single-use
Type: General Medical Device
Manufacturer: Safeway Industry Healthcare
Surgical cap, single-use
Type: General Medical Device
Manufacturer: Safeway Industry Healthcare
Surgical/medical face mask, non-antimicrobial, single-use
Type: General Medical Device
Manufacturer: Safeway Industry Healthcare
Physical therapy transcutaneous neuromuscular electrical stimulation system
Type: General Medical Device
Manufacturer: Mingna (Guangzhou) Technology Co., Ltd.
Dental impression tray, single-use
Type: General Medical Device
Manufacturer: Nanchang White Technology Co., Ltd.
Dressing-fixation skin adhesive tape, non-silicone
Type: General Medical Device
Manufacturer: Nanjing 3H Medical Products Co., Ltd.
Laryngeal mask airway, single-use
Type: General Medical Device
Manufacturer: NANCHANG YILI MEDICAL INSTRUMENT CO., LTD
Burn gel
Type: General Medical Device
Manufacturer: Roosin Medical Co., Ltd.

