Home›China›Winner Medical Co., Ltd.

Winner Medical Co., Ltd.

China · Shenzhen Guangdong · www.winnermedical.com

✓ Record-verifiedregistrations found in 13 marketsEU SRN CN-MF-000005692Unified social credit code 91440300723009295R

This company holds 43 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

43China registrations

Class I 17Class II 24Class III 2

as of 2026-09-04

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class I 45Class IIa 152Class IIb 103

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

USUnited StatesFDA openFDA

29listed device types

Class I 19Class II 7Class III 0unclassified 3

plus 107 registration records and 19 510(k)

UKUnited KingdomMHRA PARD

99registered device records

Class I 78Class IIa 11Class IIb 10

BRBrazilANVISA

48registered devices

Class I 19Class II 29

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

SASaudi ArabiaSFDA

10registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Manufacturing 1

AUAustraliaTGA ARTG

45active ARTG entries

Class I 16IIa 2IIb 18Class Is (sterile) 9

HKHong KongMDACS

4valid listings

Class II 1Class IV 3

ILIsraelAMAR

19registrations

RURussiaRoszdravnadzor

4active registrations

Class 1 4

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 Union655 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States107 registration records, 19 510(k), 0 PMA, 2 excluded

China43 certificates (Class III 2 / II 24 / I 17), as of 2026-09-04

United Kingdom99 confirmed, 1 excluded

Brazil48 confirmed, 4 excluded

Saudi Arabia10 confirmed, 0 excluded

Manufacturer names merged into this page: WINNER MEDICAL CO., LTD. · Winner Medical (Chongyang) Co., Ltd. · Winner Medical (Jiayu) Co., Ltd. · Winner Medical (Wuhan) Co., Ltd. · WINNER MEDICAL (HUNAN) CO. LTD. · XIAMEN WINNER MEDICAL CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000005692
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: MedPath Limited
Unified social credit code: 91440300723009295R
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2000-08-24
Registered capital: CNY 582,329,808
Paid-in capital: CNY 582,970,928
Legal form: Joint-stock limited company (foreign-invested, listed)
Industry classification: Textiles
Last approval date: 2025-11-13
Recognitions: National High-Tech EnterpriseManufacturing Single ChampionAbove-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

12005

12019

22020

12021

42022

82023

22025

FDA listed device types

showing 8 of 29

Cap, Surgical 1Pad, Eye 1Solvent, Adhesive Tape 1Needle, Aspiration And Injection, Disposable 1Dressing, Wound, Occlusive 1Tape And Bandage, Adhesive 1Elastomer, Silicone, For Scar Management 1Bandage, Liquid, Skin Protectant 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20253140580	亲水性纤维敷料	Class III
CN	国械注准20253140148	软聚硅酮泡沫敷料	Class III
CN	粤械注准20262160100	眼部热敷治疗贴	Class II
CN	粤械注准20252141196	负压引流护创材料	Class II
EU	03664492021867	—	Class I
EU	03615370006865	Compresses Oculaires	Class I
EU	03664492015132	—	Class I
EU	03664492015187	—	Class I
UK	61850	Nursing Pad	Class I
UK	34864	Cotton elastic adhesive bandage	Class I
UK	16545	Surgical packs	Class I
US	K252001	Collagen Wound Dressing	2025-10-10
US	K250082	Procedure mask/Surgical mask/Face mask	2025-06-18
US	K231057	Antibacterial Gel Wound Dressing	2023-12-01
BR	82045360003	SMED Seringa Luer Lock 0,5ml sem agulha de insulina	Class I
BR	80937159122	SOL M Agulha para Coleta de Sangue a Vácuo	Class II
BR	80937150088	Sol-Care Adaptador com Dispositivo de Segurança	Class I
SA	ME0000005421SFDAA00042	Adhesive Remover pad	—
SA	ME0000005421SFDAA00044	Silicone tape	—