HomeChinaSHENZHEN SOPHWAY TECHNOLOGY CO.,LTD.

SHENZHEN SOPHWAY TECHNOLOGY CO.,LTD.

China · 深圳 · www.sophway.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000027700Unified social credit code 91440300MA5FM3403F

This company holds 7 NMPA certificates in China and has registrations in European Union, United States, Brazil, Russia — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
7China registrations
Class II 7
as of 2026-09-04
EUEuropean UnionEUDAMED
14UDI-DI device records
Class I 10Class IIa 4
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 3 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
5registered devices
Class I 1Class II 4
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
1active registrations
Class 2a 1
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 Union14 raw hits, 0 excluded, 14 confirmed
United States3 registration records, 2 510(k), 0 PMA
China7 certificates (Class III 0 / II 7 / I 0), as of 2026-09-04
Brazil5 confirmed, 0 excluded
Manufacturer names merged into this page: SHENZHEN SOPHWAY TECHNOLOGY CO., LTD. · SHENZHEN SOPHWAY TECHNOLOGY CO.,LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000027700
EU authorised representative
Umedwings Netherlands B.V.
Unified social credit code
91440300MA5FM3403F
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
41
Annual revenue
under RMB 5M
Website
www.sophway.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
2019-05-20
Registered capital
CNY 11,289,600
Paid-in capital
CNY 11,289,600
Legal form
Limited liability company
Industry classification
Special-purpose equipment manufacturing
Last approval date
2024-06-21
Recognitions
Micro and small enterpriseNational High-Tech 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

22025 · K250551

FDA listed device types

Endoscopic Video Imaging System/Component, Gastroenterology-Urology 1Led Light Source 1Laparoscope, General & Plastic Surgery 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准202520612424K三维内窥镜摄像系统Class II
CN粤械注准20252061019三维腹腔内窥镜Class II
CN粤械注准20242060436腹腔内窥镜Class II
CN粤械注准202320609014K内窥镜摄像系统Class II
EU06973563045518InsufflatorClass IIa
EU06973563045501InsufflatorClass IIa
EU06973563045495InsufflatorClass IIa
EU06973563045488InsufflatorClass IIa
USK2505514K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)2025-10-02
USK250204Endoscopic Camera System2025-07-01
BR82195309032Sistema de câmera endoscópicaClass II
BR82195300014Fonte de luz LED endoscópicaClass I
BR82195309037InsufladorClass II

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