HomeChinaNanjing Kangni Smart Technologies CO., Ltd.

Nanjing Kangni Smart Technologies CO., Ltd.

China · 南京 · www.kangnismart.cn/about.html
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000012186Unified social credit code 91320106MA1MRX8D3J

This company holds 15 NMPA certificates in China and has registrations in European Union, United States, United Kingdom — 3 overseas markets. EU UDI-DI records ≥281, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
15China registrations
Class I 8Class II 7
as of 2026-09-04
EUEuropean UnionEUDAMED
≥281UDI-DI device records
Class I 281
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 2 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class I 1
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 Union509 raw hits, 19 excluded, 281 confirmed. Large result set — only the first 300 verified
United States2 registration records, 2 510(k), 0 PMA
China15 certificates (Class III 0 / II 7 / I 8), as of 2026-09-04
United Kingdom1 confirmed, 1 excluded
Manufacturer names merged into this page: NANJING KANGNI SMART TECHNOLOGY CO.,LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000012186
EU authorised representative
SUNGO Europe B.V.
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
91320106MA1MRX8D3J
Exhibition record
Rehab & Elderly Care Expo (Spring 2026, Shanghai) · Rehab & Elderly Care Expo (Spring 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
51
Annual revenue
RMB 5–10M
Website
www.kangnismart.cn/about.html
Product categories
家用器械医用康复器械养老用品

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
2016-08-18
Registered capital
CNY 20,000,000
Paid-in capital
CNY 20,000,000
Legal form
Limited liability company (wholly owned by a non-natural-person corporation)
Industry classification
Technology promotion and application services
Last approval date
2025-07-29
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 · K252494

FDA listed device types

Vehicle, Motorized 3-Wheeled 1Wheelchair, Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
CN苏械注准20262190539电动轮椅车Class II
CN苏械注准20262190274电动轮椅车Class II
CN苏械注准20232150392医用电动转移车Class II
CN苏械注准20232150195电动病床Class II
EU06972665814275Class I
EU06972665813988Class I
EU06972665813971Class I
EU06972665813964Class I
UK45684Folding Mobility ScooterClass I
USK252494Electrically powered wheelchair (KZ301B)2025-12-05
USK252502Folding Mobility Scooter (KD101)2025-10-06

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