HomeChinaXuzhou AKX Electronic Science and Technology co.,Ltd

Xuzhou AKX Electronic Science and Technology co.,Ltd

China · 徐州 · www.xzikeda.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000031488Unified social credit code 913203036789699234

This company holds 11 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
11China registrations
Class II 11
as of 2026-09-04
EUEuropean UnionEUDAMED
107UDI-DI device records
Class I 107
USUnited StatesFDA openFDA
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
3registered devices
Class II 3
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
0valid device licences
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 Union107 raw hits, 0 excluded, 107 confirmed
United States1 registration records, 0 510(k), 0 PMA
China11 certificates (Class III 0 / II 11 / I 0), as of 2026-09-04
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: Xuzhou AKX Electronic Science and Technology Co., Ltd · XUZHOU AKX ELECTRONIC SCIENCE AND TECHNOLOGY CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000031488
EU authorised representative
SUNGO Europe B.V.
Unified social credit code
913203036789699234
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
65
Annual revenue
RMB 10–30M
Website
www.xzikeda.com
Product categories
医用成像器械妇产科、辅助生殖和避孕器械

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
2008-07-30
Registered capital
CNY 12,000,000
Paid-in capital
CNY 10,000,000
Legal form
Limited liability company
Industry classification
Special-purpose equipment manufacturing
Last approval date
2023-09-18
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 listed device types

Camera, Cine, Endoscopic, Without Audio 1

Registration details (sample)

MarketIdentifierNameClass / date
CN苏械注准20252062359气腹机Class II
CN苏械注准20252062335二氧化碳气腹机Class II
CN苏械注准20252062198三晶片内窥镜摄像系统Class II
CN苏械注准202520609614K荧光内窥镜摄像系统Class II
EU06973787581144Class I
EU06973787581137Class I
EU06973787581120Class I
EU06973787581113Class I
BR80082919084SISTEMA DE VÍDEO COMPACTO - VIZIO TAIMINClass II
BR80454389010ENDOCAM-VÍDEO CÂMERA ENDOSCÓPICA-ORTOSPINEClass II
BR81784929005VÍDEO PROCESSADORA E CÂMERA ENDOSCÓPICAClass II

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