HomeChinaZhongshan Sulenz intelligent Technology Co., LTD

Zhongshan Sulenz intelligent Technology Co., LTD

China · 中山
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000047504Unified social credit code 91442000MA52Q0R87L

This company holds 4 NMPA certificates in China and has registrations in European Union, United States, United Kingdom — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
4China registrations
Class I 2Class II 2
as of 2026-09-04
EUEuropean UnionEUDAMED
20UDI-DI device records
Class I 20
USUnited StatesFDA openFDA
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
3registered device records
Class I 3
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 Union20 raw hits, 0 excluded, 20 confirmed
United States0 registration records, 1 510(k), 0 PMA
China4 certificates (Class III 0 / II 2 / I 2), as of 2026-09-04
United Kingdom3 confirmed, 0 excluded

Regulatory identity

EU manufacturer SRN
CN-MF-000047504
EU authorised representative
SUNGO Europe B.V.
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
91442000MA52Q0R87L
Exhibition record
Rehab & Elderly Care Expo (Spring 2026, Shanghai) · Rehab & Elderly Care Expo (Spring 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
23
Annual revenue
RMB 30–50M

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
2018-12-29
Registered capital
CNY 1,000,000
Paid-in capital
CNY 1,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Technology promotion and application services
Last approval date
2026-05-19
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

12026 · K260335

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20212190817手动轮椅车Class II
CN粤械注准20212190034电动轮椅车Class II
CN粤中械备20220064号医用拐Class I
CN粤中械备20220063号助行器Class I
EU06976791310113Class I
EU06976791310106Class I
EU06976791310090Class I
EU06976791310083Class I
UK41875Electric WheelchairClass I
UK37951RollatorClass I
UK41512Manual WheelchairClass I
USK260335Electric Wheelchair (S500-6)2026-06-15

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