HomeChinaHimaging Technology (Shanghai) Co., Ltd.

Himaging Technology (Shanghai) Co., Ltd.

China · 上海 · www.himaging.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000028002Unified social credit code 91310118MA1JLG7419

This company holds 4 NMPA certificates in China and has registrations in European Union, United States — 2 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
4China registrations
Class II 4
as of 2026-09-04
EUEuropean UnionEUDAMED
29UDI-DI device records
Class I 1Class IIa 28
USUnited StatesFDA openFDA
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(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
pendingnot queried
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 Union29 raw hits, 0 excluded, 29 confirmed
United States0 registration records, 1 510(k), 0 PMA
China4 certificates (Class III 0 / II 4 / I 0), as of 2026-09-04

Regulatory identity

EU manufacturer SRN
CN-MF-000028002
EU authorised representative
Lotus NL B.V.
Unified social credit code
91310118MA1JLG7419
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
Social-insurance enrolees
40
Annual revenue
RMB 10–30M
Website
www.himaging.com

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
2016-09-05
Registered capital
CNY 1,627,660
Paid-in capital
CNY 1,477,660
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Software and IT services
Last approval date
2025-08-01
Recognitions
Micro and small enterpriseNational High-Tech Enterprise

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

12025 · K251894

Registration details (sample)

MarketIdentifierNameClass / date
CN沪械注准20252060203一次性使用软性支气管电子内窥镜Class II
CN沪械注准20252060142一次性使用软性鼻咽喉电子内窥镜Class II
CN沪械注准20242060372电子内窥镜图像处理器Class II
CN沪械注准20242060339一次性使用软性膀胱电子内窥镜导管Class II
EU06974235401335Single-use Flexible Video Rhino-LaryngoscopeClass IIa
EU06974235401083Single-use Flexible Video Rhino-LaryngoscopeClass IIa
EU06974235401342Single-use Flexible Video Rhino-LaryngoscopeClass IIa
EU06974235401106Single-use Flexible Video UreterorenoscopeClass IIa
USK251894Himaging Bronchscope System2025-09-23

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