HomeChinaSHENZHEN LUCKCOME TECHNOLOGY,.LTD

SHENZHEN LUCKCOME TECHNOLOGY,.LTD

China · 深圳 · www.luckcome.com
✓ Record-verifiedregistrations found in 4 marketsUnified social credit code 91440300757610169J

This company holds 22 NMPA certificates in China and has registrations in United States, Brazil, Taiwan — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
22China registrations
Class II 22
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
2registered devices
Class II 2
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
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.

United States0 registration records, 1 510(k), 0 PMA
China22 certificates (Class III 0 / II 22 / I 0), as of 2026-09-04
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: SHENZHEN LUCKCOME TECHNOLOGY INC., LTD.

Regulatory identity

Unified social credit code
91440300757610169J
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
66
Annual revenue
RMB 30–50M
Website
www.luckcome.com
Product categories
妇产科、辅助生殖和避孕器械妇产及生殖医用诊察和监护器械

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
2003-12-10
Registered capital
CNY 5,850,000
Paid-in capital
CNY 5,850,000
Legal form
Joint-stock limited company (unlisted)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2025-08-11
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseAbove-designated-size industrial enterprise
Listing
Delisted from the NEEQ

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

12019 · K182710

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20262220023尿液分析仪Class II
CN粤械注准20262070893电子血压计Class II
CN粤械注准20262070470生理参数检测仪Class II
CN粤械注准20252181409多参数胎儿心率仪Class II
USK182710Fetal Doppler, Model FD882019-03-01
BR80127849013MONITOR FETAL DOPPLERClass II
BR80127849016DETECTOR DE ICTERICIAClass II

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