Home›China›ZHEJIANG UE MEDICAL CORP.

ZHEJIANG UE MEDICAL CORP.

✓ Record-verifiedregistrations found in 11 markets

This company holds 63 NMPA certificates in China and has registrations in United States, United Kingdom, Saudi Arabia, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 overseas markets.

Registrations by market

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

CNChinaNMPA

63China registrations

Class I 4Class II 59

as of 2026-09-04

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

6listed device types

Class I 5Class II 1Class III 0

plus 6 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

10registered device records

Class I 6Class IIa 4

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

6registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

4valid device licences

Class I 4

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

5active ARTG entries

Class I 2IIa 1IIb 1Class Is (sterile) 1

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

19registrations

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 Union56,720 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States6 registration records, 1 510(k), 0 PMA, 5 excluded

China63 certificates (Class III 0 / II 59 / I 4), as of 2026-09-04

United Kingdom10 confirmed, 161 excluded

Saudi Arabia6 confirmed, 0 excluded

Manufacturer names merged into this page: Zhejiang UE Medical Corp. · Zheijiang UE Medical Corp.

Regulatory identity

UK responsible person: lotus global co ltd
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2010-09-02
Registered capital: CNY 72,000,000
Paid-in capital: CNY 72,000,000
Legal form: Joint-stock limited company (foreign-invested)
Industry classification: Retail trade
Last approval date: 2025-11-12
Recognitions: National High-Tech EnterpriseTechnology-based SMERecognised enterprise technology centre

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

12025 · K251823

FDA listed device types

Stylet, Tracheal Tube 1Laryngoscope, Rigid 1Cart, Emergency, Cardiopulmonary (Excluding Equipment) 1Laryngoscope, Non-Rigid 1Airway, Oropharyngeal, Anesthesiology 1Bronchoscope (Flexible Or Rigid) 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	浙械注准20262060454	医用内窥镜冷光源	Class II
CN	浙械注准20262060130	一次性导航视频探头	Class II
CN	浙械注准20262020059	一次性使用支气管镜延长鞘管	Class II
CN	浙械注准20252081749	一次性使用无菌气管插管套件	Class II
UK	56654	UE display	Class I
UK	44962	Flexible Videoscopes	Class IIa
UK	45036	Disposable Medical Laryngeal Masks	Class IIa
US	K251823	UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S)	2025-08-11
SA	ME0000005763SFDAA00013	Video Laryngoscope UED-C series	—
SA	ME0000005763SFDAA00009	UESCOPE LARYNGOSCOPE BLADES	—