HomeChinaXUZHOU KAIXIN ELECTRONIC INSTRUMENT CO.,LTD.

XUZHOU KAIXIN ELECTRONIC INSTRUMENT CO.,LTD.

China · Xuzhou Jiangsu · www.kxele.com
✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000040932Unified social credit code 913203016080161665

This company holds 9 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, South Korea, Australia, Hong Kong, Russia — 9 overseas markets. EU UDI-DI records ≥6, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
9China registrations
Class II 9
as of 2026-09-04
EUEuropean UnionEUDAMED
≥6UDI-DI device records
Class IIa 6
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
2listed device types
Class I 0Class II 2Class III 0
plus 1 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class IIa 1
BRBrazilANVISA
4registered devices
Class 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
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
3active ARTG entries
IIa 3
HKHong KongMDACS
1valid listings
Class II 1
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 Union573 raw hits, 294 excluded, 6 confirmed. Large result set — only the first 300 verified
United States1 registration records, 1 510(k), 0 PMA
China9 certificates (Class III 0 / II 9 / I 0), as of 2026-09-04
United Kingdom1 confirmed, 4 excluded
Brazil4 confirmed, 0 excluded
Manufacturer names merged into this page: XUZHOU KAIXIN ELECTRONIC INSTRUMENT CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000040932
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
RED DRAGON INVESTMENTS LIMITED
Unified social credit code
913203016080161665
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Xuzhou Jiangsu
Social-insurance enrolees
105
Annual revenue
under RMB 5M
Website
www.kxele.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesDiagnostics, Imaging & Nuclear MedicineRadiology & Imaging SystemsUltrasound (POCUS, AI-guided, portable)

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
1997-04-03
Registered capital
CNY 10,000,000
Paid-in capital
CNY 10,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2021-11-30
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMESRDI SME

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

12023 · K223448

FDA listed device types

Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1

Registration details (sample)

MarketIdentifierNameClass / date
CN苏械注准20252060114彩色多普勒超声系统Class II
CN苏械注准20242061827全数字彩色多普勒超声诊断仪Class II
CN苏械注准20222161211眼科A型超声测量仪Class II
CN苏械注准20222160762眼科AB型超声诊断仪Class II
EUD-BVT01YVBladder Volume TesterClass IIa
EU06974784890024Ophthalmological ultrasonic measuring instrumentsClass IIa
EU06974784890017Ophthalmological ultrasonic measuring instrumentsClass IIa
EU06974784890000Ophthalmological A/B mode ultrasound scannerClass IIa
UK41501Ultrasonic Diagnostic Instruments Bladder ScannerClass IIa
USK223448Bladder Scanner Model: BVT022023-07-07
BR80310289012Scanner de Ultrassom Oftalmológico modo A / BClass II
BR81405509001ULTRASSOM OFTALMOLÓGICO MÓDULOS A/BClass II
BR81405509002instrumentos oftalmológicos de medição ultrassônicaClass II

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