HomeChinaQingdao hisense Medical Equipment co.,ltd

Qingdao hisense Medical Equipment co.,ltd

China · 青岛 · med.hisense.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000047224Unified social credit code 91370200092952040E

This company holds 18 NMPA certificates in China and has registrations in European Union, United States, Israel — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
18China registrations
Class II 14
as of 2026-09-04
EUEuropean UnionEUDAMED
213UDI-DI device records
Class I 16Class IIa 197
USUnited StatesFDA openFDA
5listed device types
Class I 1Class II 4Class III 0
plus 9 registration records and 9 510(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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
pendingnot queried
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 Union215 raw hits, 2 excluded, 213 confirmed
United States9 registration records, 9 510(k), 0 PMA
China18 certificates (Class III 0 / II 14 / I 0), as of 2026-09-04
United Kingdom0 confirmed, 1 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: Qingdao Hisense Medical Equipment Co.,Ltd. · QINGDAO HISENSE MEDICAL CO., LTD.
Same-named companies — This database also contains companies with near-identical names: Qingdao Hisense Medical Co., Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Regulatory identity

EU manufacturer SRN
CN-MF-000047224
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Unified social credit code
91370200092952040E
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
250
Annual revenue
over RMB 500M
Website
med.hisense.com
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
2014-02-28
Registered capital
CNY 40,000,000
Paid-in capital
CNY 40,000,000
Legal form
Joint-stock limited company (unlisted)
Industry classification
Research and experimental development
Last approval date
2024-05-31
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SMEState Key Laboratory

Business registration data from Tianyancha, as of 2026-09-03. 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

22015 · K152030
12016 · K160347
42022 · K222208
22024 · K233841

FDA listed device types

Display, Diagnostic Radiology 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Doppler, Ultrasonic 1System, Imaging, Pulsed Echo, Ultrasonic 1Camera, Television, Surgical, Without Audio 1

Registration details (sample)

MarketIdentifierNameClass / date
CN鲁械注准20242211037医学影像处理软件Class II
CN鲁械注准20242060852医用内窥镜冷光源Class II
CN鲁械注准202420608414K内窥镜摄像系统Class II
CN鲁械注准20242060619便携式彩色多普勒超声诊断系统Class II
EU06978311952056HisenseClass IIa
EU06978311952049HisenseClass IIa
EU06978311952032HisenseClass IIa
EU06978311952025HisenseClass IIa
USK233841HD80 Series Ultrasound Diagnostic System2024-05-16
USK233439HD60 Series Ultrasound Diagnostic System2024-02-21
USK222208Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D2022-11-17

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