HomeChinaBeijing Wandong Medical Technology Co., Ltd.

Beijing Wandong Medical Technology Co., Ltd.

China · 北京 · www.wandong.com.cn
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000014174Unified social credit code 9111000063379674X4

This company holds 67 NMPA certificates in China and has registrations in European Union, United States, Taiwan, Russia — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
67China registrations
Class I 3Class II 30Class III 34
as of 2026-09-04
EUEuropean UnionEUDAMED
58UDI-DI device records
Class IIa 19Class IIb 39
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 5 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
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
0active device licences
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 2b 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 Union58 raw hits, 0 excluded, 58 confirmed
United States5 registration records, 5 510(k), 0 PMA
China67 certificates (Class III 34 / II 30 / I 3), as of 2026-09-04
Brazil0 confirmed, 1 excluded
Manufacturer names merged into this page: MRI DIVISION, Beijing Wandong Medical Technology Co.,Ltd
Same-named companies — This database also contains companies with near-identical names: Beijing Wandong Dingli Medical Equipment Co., Ltd., Beijing Wandong Medical Equipment Co., Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Regulatory identity

EU manufacturer SRN
CN-MF-000014174
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Unified social credit code
9111000063379674X4
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
994
Annual revenue
over RMB 500M
Website
www.wandong.com.cn
Product categories
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
1997-05-12
Registered capital
CNY 703,061,058
Paid-in capital
CNY 703,061,058
Legal form
Joint-stock limited company (listed)
Industry classification
Pharmaceutical manufacturing
Last approval date
2026-04-22
Recognitions
National High-Tech EnterpriseSRDI SMEGazelle 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

12004 · K042948
22009 · K090873
12021 · K192650
12022 · K221025

FDA listed device types

System, Nuclear Magnetic Resonance Imaging 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263061647超导型磁共振成像系统Class III
CN国械注准20263061040医用血管造影X射线机Class III
CN国械注准20263060553磁共振成像系统Class III
CN国械注准20253062378X射线计算机体层摄影设备Class III
EU06938964317091Class IIb
EU06938964326017Class IIb
EU06938964324037Class IIb
EU06938964312881Class IIb
USK221025i_ Field 1.5T Superconducting Magnetic Resonance Imaging System2022-07-01
USK192650i_Space 1.5T Superconducting Magnetic Resonance Imaging System2021-01-29
USK090873I OPEN 0.5T2009-04-10

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