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Shenzhen HugeMed Medical Technical Development Co.,Ltd.

✓ Record-verifiedregistrations found in 14 marketsEU SRN CN-MF-000010895Unified social credit code 914403003059314716

This company holds 19 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 13 overseas markets.

Registrations by market

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

CNChinaNMPA

19China registrations

Class II 19

as of 2026-09-04

EUEuropean UnionEUDAMED

113UDI-DI device records

Class I 63Class IIa 50

USUnited StatesFDA openFDA

21listed device types

Class I 6Class II 15Class III 0

plus 19 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

14registered device records

Class I 4Class IIa 10

BRBrazilANVISA

18registered devices

Class I 1Class II 17

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

SASaudi ArabiaSFDA

16registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

11 including historic records

TWTaiwanTFDA

7valid device licences

Class I 5Class II 2

SGSingaporeHSA SMDR

6device registrations

CLASS B 6

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

11active ARTG entries

Class I 3IIa 8

HKHong KongMDACS

4valid listings

Class II 4

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 Union113 raw hits, 0 excluded, 113 confirmed

United States19 registration records, 8 510(k), 0 PMA

China19 certificates (Class III 0 / II 19 / I 0), as of 2026-09-04

United Kingdom14 confirmed, 0 excluded

Brazil18 confirmed, 0 excluded

Saudi Arabia16 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD · SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD. · SHENZHEN HUGEMED TECHNICAL DEVELOPMENT CO. LTD. ( MAWU ROAD) · Shenzhen HugeMed Medical Technical Development Co Ltd · Shenzhen HugeMed Medical Technical Development Co.,Ltd · Shenzhen Hugemed Medical Technical Development Co. Ltd.

Regulatory identity

EU manufacturer SRN: CN-MF-000010895
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: Umedwings UK LTD
Unified social credit code: 914403003059314716
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2014-05-06
Registered capital: CNY 21,879,266
Paid-in capital: CNY 16,850,811
Legal form: Joint-stock limited company (foreign-invested)
Industry classification: Other manufacturing
Last approval date: 2026-08-31
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseSRDI SME

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

22023 · K231118

32024 · K240374

22025 · K250695

12026 · K260892

FDA listed device types

showing 8 of 21

Dislodger, Stone, Basket, Ureteral, Metal 1Nasopharyngoscope (Flexible Or Rigid) 1Bronchoscope (Flexible Or Rigid) 1Cystoscope And Accessories, Flexible/Rigid 1Cable, Electrode 1Cable, Transducer And Electrode, Patient, (Including Connector) 1Endoscopic Video Imaging System/Component, Gastroenterology-Urology 1Endoscopic Access Overtube, Gastroenterology-Urology 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	粤械注准20262060959	电子胆道镜	Class II
CN	粤械注准20262060633	医用内窥镜图像处理器	Class II
CN	粤械注准20262060416	电子膀胱肾盂镜	Class II
CN	粤械注准20262060222	电子鼻咽喉内窥镜	Class II
EU	06970462540823	—	Class I
EU	06970462540816	—	Class I
EU	06970462540809	—	Class I
EU	06970462540793	—	Class I
UK	38703	Flexible Video Ureterorenoscope	Class IIa
UK	66115	Single-use Collector	Class I
UK	18034	Medical Image Processor	Class IIa
US	K260892	Suction Pump (SU-90)	2026-05-14
US	K250695	Single-use Ureteral Access Sheath	2025-07-08
US	K241444	Biliary Pancreaticobiliary Scope System	2025-01-21
BR	80686369109	Processador de Imagem	Class II
BR	80686369110	Ureterorrenoscópio de Vídeo Flexível Reutilizável	Class II
BR	80102519301	Ureterorrenoscópio de vídeo flexível Dornier Axis Leo	Class II
SA	ME0000011505SFDAA00010	Video Laryngoscope	—
SA	ME0000011505SFDAA00012	Video Laryngoscope Blade	—
CA	110143	FLEXIBLE VIDEO URETERORENOSCOPE	Class II