HomeChinaShanghai SIGMA High-tech Co., Ltd.

Shanghai SIGMA High-tech Co., Ltd.

China · 上海 · www.sigmamed.net
✓ Record-verifiedregistrations found in 2 marketsUnified social credit code 913101181327279499

This company holds 17 NMPA certificates in China and has registrations in United States — 1 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
17China registrations
Class I 1Class II 16
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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 Union1,104 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified
United States1 registration records, 1 510(k), 0 PMA, 26 excluded
China17 certificates (Class III 0 / II 16 / I 1), as of 2026-09-04
United Kingdom0 confirmed, 5 excluded
Brazil0 confirmed, 3 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada0 confirmed, 5 excluded
Manufacturer names merged into this page: SHANGHAI SIGMA HIGH-TECH CO., LTD.

Regulatory identity

Unified social credit code
913101181327279499
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
90
Annual revenue
RMB 50–100M
Website
www.sigmamed.net
Product categories
物理治疗器械医用成像器械

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
1992-08-18
Registered capital
CNY 23,943,320
Paid-in capital
CNY 23,943,320
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Professional technical services
Last approval date
2024-08-05
Recognitions
National 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

12024 · K242908

FDA listed device types

Light, Ultraviolet, Dermatological 1

Registration details (sample)

MarketIdentifierNameClass / date
CN沪械注准20262070123紫外光诊察灯Class II
CN沪械注准20252090290强脉冲光治疗仪Class II
CN沪械注准20222090223紫外线光疗仪Class II
CN沪械注准20222090210紫外线光疗仪Class II
USK242908UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)2024-12-19

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