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Well Lead Medical Co., Ltd.

✓ Record-verifiedregistrations found in 13 marketsEU SRN CN-MF-000006728Unified social credit code 91440101759431420M

This company holds 104 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 overseas markets. EU UDI-DI records ≥278, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

104China registrations

Class I 13Class II 88Class III 3

as of 2026-09-04

EUEuropean UnionEUDAMED

≥278UDI-DI device records

Class I 47Class IIa 208Class IIb 23

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

47listed device types

Class I 17Class II 30Class III 0

plus 96 registration records and 23 510(k)

UKUnited KingdomMHRA PARD

275registered device records

Class I 31Class IIa 227Class IIb 16System or Procedure Pack 1

BRBrazilANVISA

142registered devices

Class I 24Class II 118

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

6active device licences

Class II 6

44 including historic records

TWTaiwanTFDA

15valid device licences

Class I 2Class II 13

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

11GMP quality-system certificates

Business type not stated 1Import 10

AUAustraliaTGA ARTG

79active ARTG entries

Class I 4IIa 38IIb 29Class Im (measuring) 1Class Is (sterile) 7

HKHong KongMDACS

6valid listings

Class II 6

ILIsraelAMAR

15registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union2,310 raw hits, 22 excluded, 278 confirmed. Large result set — only the first 300 verified

United States96 registration records, 23 510(k), 0 PMA, 10 excluded

China104 certificates (Class III 3 / II 88 / I 13), as of 2026-09-04

United Kingdom275 confirmed, 3 excluded

Brazil142 confirmed, 0 excluded

Canada6 confirmed, 2 excluded

Manufacturer names merged into this page: WELL LEAD MEDICAL CO. LTD · WELL LEAD MEDICAL (HAINAN) CO., LTD. · WELL LEAD MEDICAL CO., LTD. · WELL LEAD MEDICAL CO, LTD · WELL LEAD MEDICAL INSTRUMENTS CO LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000006728
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: SUNGO Certification Company Limited
Unified social credit code: 91440101759431420M
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2004-04-30
Registered capital: CNY 291,871,418
Paid-in capital: CNY 291,871,418
Legal form: Joint-stock limited company (listed)
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2025-12-10
Recognitions: National High-Tech EnterpriseRecognised enterprise technology centreAbove-designated-size industrial enterprise
Listing: Listed on the A-share market

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

22005

22008

12009

12010

12011

32014

32016

12017

12019

12020

12021

32022

12023

12024

12025

FDA listed device types

showing 8 of 47

Cystoscope And Accessories, Flexible/Rigid 1Endoscopic Guidewire, Gastroenterology-Urology 1Endoscopic Access Overtube, Gastroenterology-Urology 1Bottle, Collection, Vacuum 1Biopsy Needle Guide Kit 1Kit, Nephroscope 1Tube, Double Lumen For Intestinal Decompression And/Or Intubation 1Catheter, Retention Type, Balloon 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20243141963	一次性使用无菌导尿管	Class III
CN	国械注准20243082067	超声引导神经阻滞麻醉穿刺针	Class III
CN	国械注准20163031270	一次性无菌中心静脉导管套件	Class III
CN	粤械注准20262140353	一次性间歇性导尿管	Class II
EU	06944932765788	Tracheal Tube	Class IIa
EU	06944932765771	Tracheal Tube	Class IIa
EU	06944932765764	Tracheal Tube	Class IIa
EU	06944932765757	Tracheal Tube	Class IIa
UK	35142	Nebulizer Kit	Class IIa
UK	35142	Nebulizer Kit	Class IIa
UK	35142	Nebulizer Kit	Class IIa
US	K241734	Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact	2025-03-05
US	K233094	Wellead® Latex Foley Catheter	2024-06-06
US	K220722	PVC Hydrophilic Urethral Catheter	2023-05-22
BR	10150479064	TAMPA PROTETORA PARA SONDA WILTEX	Class I
BR	10369460191	SONDA DE FOLEY SILICONE SOLIDOR	Class II
BR	10150470609	Sonda Foley em látex siliconizado well lead	Class II
CA	78847	PARKER EASYCURVE TRACHEAL TUBE	Class II
CA	78848	REINFORCED LARYNGEAL MASK AIRWAY - SILICONE	Class II
CA	78850	PARKER FLEX-IT STYLETS	Class II