HomeChinaEIZO Corporation

EIZO Corporation

China · 苏州 · www.eizo.com.cn
✓ Record-verifiedregistrations found in 9 marketsEU SRN JP-MF-000016570Unified social credit code 91320594552478205K

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Australia, Israel, Russia — 9 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
0China registrations
as of 2026-09-01
EUEuropean UnionEUDAMED
≥300UDI-DI device records
Class I 300
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
9listed device types
Class I 4Class II 5Class III 0
plus 35 registration records and 32 510(k)
UKUnited KingdomMHRA PARD
9registered device records
Class I 8IVD A 1
BRBrazilANVISA
2registered devices
Class I 2
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
13registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
Class I 5
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
4active registrations
Class 2a 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 Union906 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States35 registration records, 32 510(k), 0 PMA, 1 excluded
China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01
United Kingdom9 confirmed, 0 excluded
Brazil2 confirmed, 0 excluded
Saudi Arabia13 confirmed, 0 excluded
Manufacturer names merged into this page: EIZO CORPORATION · EIZO GmbH · EIZO Corporation

Regulatory identity

EU manufacturer SRN
JP-MF-000016570
EU authorised representative
EIZO GmbH
UK responsible person
EIZO Limited
Unified social credit code
91320594552478205K
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
65
Annual revenue
RMB 100–500M
Website
www.eizo.com.cn
Product categories
医用影像医用成像器械

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2010-03-29
Registered capital
USD 9,000,000
Paid-in capital
USD 9,000,000
Legal form
Limited liability company (wholly owned by a foreign corporation)
Industry classification
Computer, communications and other electronic equipment
Last approval date
2026-04-30
Recognitions
Micro and small enterprise

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

12008
22011
12013
42014
32015
42016
22017
32018
12019
12020
12021
12022
42023
22024
22025

FDA listed device types

showing 8 of 9
Display, Cathode-Ray Tube, Medical 1System, Image Processing, Radiological 1Display, Diagnostic Radiology 1Digital Pathology Display 1Laparoscope, General & Plastic Surgery 1Camera, Surgical And Accessories 1System, Digital Image Communications, Radiological 1Device, Digital Image Storage, Radiological 1

Registration details (sample)

MarketIdentifierNameClass / date
EU04995047065685RadiForce MX243W-FHBKClass I
EU04995047063056RadiForce MS236WT-AFGYClass I
EU04995047060321RadiForce RX560-BK-MDClass I
EU04995047060192RadiForce GX560-BK-MD-NClass I
UK67566PX3150IVD A
UK56654CuratOR EX2620Class I
UK36612RadiForce MS236WT-AClass I
USK252030RadiForce GX570; RadiForce GX570-AR2025-08-28
USK242545RadiForce MX317W-PA2025-05-23
USK243221RadiForce RX570; RadiForce RX570-AR2024-11-27
BR81596770003MONITORES DE USO CIRÚRGICO EIZOClass I
BR81596770002EIZO Monitores Médicos para Diagnóstico Multimodalidade e/ou CirurgiaClass I
SAME0000008844SFDAA00002LCD Monitor
SAME0000008844SFDAA00003EX2721

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