United Kingdom MHRA device registration 186013

Indwelling urethral drainage balloon catheter, non-antimicrobial

United Kingdom·General Medical Device·Well Lead Medical Co., Ltd.·Registered Nov 26, 2024

Registration details

Device ID: 186013
MHRA Reference Number: 186013
Date Registered: Nov 26, 2024
Last Updated: Jun 20, 2024

Device classification

Device Type: General Medical Device
Devices: Indwelling urethral drainage balloon catheter, non-antimicrobial
Type: Class IIb

Manufacturer

Name: Well Lead Medical Co., Ltd.
Address: C-4 Jinhu Industrial Estate, Hualong, Panyu
Guangzhou, China
Created Date: Jul 21, 2021

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

Wireless patient monitor/sensor reporting software, professional-onlyN/A

Type: General Medical Device

Manufacturer: GE Medical Systems Information Technologies, Inc.

Device ID: 150615

Manual blood lancing device, single-useN/A

Type: General Medical Device

Manufacturer: Tasso, Inc.

Device ID: 177275

Wireless patient monitor/sensor reporting software, professional-onlyN/A

Type: General Medical Device

Manufacturer: GE Medical Systems Information Technologies, Inc.

Device ID: 150614

Orthopaedic fixation plate, non-bioabsorbable, non-sterileN/A

Type: General Medical Device

Manufacturer: Orthofix S.r.l.

Device ID: 78945

Orthopaedic implant aiming/guiding block, reusableN/A

Type: General Medical Device

Manufacturer: Orthofix S.r.l.

Device ID: 127346

Stationary gamma camera systemN/A

Type: General Medical Device

Manufacturer: GE Medical Systems Israel Functional Imaging

Device ID: 175912

Bedside information system application softwareN/A

Type: General Medical Device

Manufacturer: GE Medical Systems Information Technologies, Inc.

Device ID: 150617

Physiologic monitoring system alarmN/A

Type: General Medical Device

Manufacturer: GE Medical Systems Information Technologies, Inc.

Device ID: 150616

Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobialN/A

Type: General Medical Device

Manufacturer: Orthofix S.r.l.

Device ID: 127370

Bone nail driverN/A

Type: General Medical Device

Manufacturer: Orthofix S.r.l.

Device ID: 113158

Other products from Well Lead Medical Co., Ltd.

Additional devices registered by the same manufacturer

Basic endotracheal tube, single-useFeb 14, 2025

Type: General Medical Device

Device ID: 210796

Basic endotracheal tube, single-useFeb 14, 2025

Type: General Medical Device

Device ID: 210777

Basic endotracheal tube, single-useFeb 14, 2025

Type: General Medical Device

Device ID: 210800

Basic endotracheal tube, single-useFeb 14, 2025

Type: General Medical Device

Device ID: 210798

Basic endotracheal tube, single-useFeb 14, 2025

Type: General Medical Device

Device ID: 210779

Basic endotracheal tube, single-useFeb 14, 2025

Type: General Medical Device

Device ID: 210778

Single-administration urethral drainage/irrigation catheterFeb 14, 2025

Type: General Medical Device

Device ID: 210725

Reinforced endotracheal tube, single-useFeb 14, 2025

Type: General Medical Device

Device ID: 210774

Intermittent urethral drainage catheter, non-antimicrobial, single-useFeb 14, 2025

Type: General Medical Device

Device ID: 210727

Basic endotracheal tube, single-useFeb 14, 2025

Type: General Medical Device

Device ID: 210769

Other products from same authorized representative

Additional devices represented by SUNGO Certification Company Limited in the UK

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

Type: In Vitro Diagnostic Device

Manufacturer: New Gene (Hangzhou) Bioengineering Co., Ltd.

Device ID: 155960

Thermal cycler nucleic acid amplification analyser IVD, laboratoryNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: RocGene (Xuzhou) Technology Limited

Device ID: 199302

SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Sensing Self Pte Ltd

Device ID: 83286

Evacuated blood collection tube IVD, clot activator/separatorNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Shenyang Bokan Biotechnology Co., Ltd.

Device ID: 112257

Evacuated blood collection tube IVD, no additiveNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Shenyang Bokan Biotechnology Co., Ltd.

Device ID: 112255

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassayNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Shenzhen Watmind Medical Co., Ltd

Device ID: 163527

D-dimer IVD, kit, chemiluminescent immunoassayNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Shenzhen Watmind Medical Co., Ltd

Device ID: 163522

Myeloperoxidase (MPO) IVD, kit, chemiluminescent immunoassayNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Shenzhen Watmind Medical Co., Ltd

Device ID: 163530

Respiratory syncytial virus (RSV) immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Shenzhen Watmind Medical Co., Ltd

Device ID: 164909

Monkeypox virus antigen IVD, kit, rapid ICT, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: New Gene (Hangzhou) Bioengineering Co., Ltd.

Device ID: 155961

About this record

Indwelling urethral drainage balloon catheter, non-antimicrobial is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 186013. The device is manufactured by Well Lead Medical Co., Ltd. from China, classified as General Medical 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 RegisteredGeneral Medical Device