HomeChinaRIZHAO SANQI MEDICAL&HEALTH ARTICLES CO., LTD.

RIZHAO SANQI MEDICAL&HEALTH ARTICLES CO., LTD.

China · 日照 · www.sanqicn.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000008918Unified social credit code 91371100168371999W

This company holds 63 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Australia — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
63China registrations
Class I 43Class II 20
as of 2026-09-04
EUEuropean UnionEUDAMED
10UDI-DI device records
Class I 10
USUnited StatesFDA openFDA
18listed device types
Class I 15Class II 2Class III 0unclassified 1
plus 19 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
5registered device records
Class I 5
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
15active ARTG entries
Class I 15
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 Union50 raw hits, 40 excluded, 10 confirmed
United States19 registration records, 1 510(k), 0 PMA, 1 excluded
China63 certificates (Class III 0 / II 20 / I 43), as of 2026-09-04
United Kingdom5 confirmed, 1 excluded
Manufacturer names merged into this page: RIZHAO SANQI MEDICAL & HEALTH ARTICLES CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000008918
EU authorised representative
SUNGO Europe B.V.
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
91371100168371999W
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
200
Annual revenue
RMB 100–500M
Website
www.sanqicn.com
Product categories
智慧健康注输、护理和防护器械医用耗材新零售

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
1993-03-29
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
Pharmaceutical manufacturing
Last approval date
2025-06-19
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

12022 · K202903

FDA listed device types

showing 8 of 18
Cap, Surgical 1Absorber, Saliva, Paper 1Gauze / Sponge,Nonresorbable For External Use 1Accessory, Surgical Apparel 1Disinfectant, Medical Devices 1Apron, Protective 1Non-Surgical Gown 1Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1

Registration details (sample)

MarketIdentifierNameClass / date
CN鲁械注准20242140443一次性使用无菌手术膜Class II
CN鲁械注准20242140121医用无纺布片Class II
CN鲁械注准20232141002一次性使用介入手术辅助包Class II
CN鲁械注准20232141001一次性使用护理包Class II
EU06956382439317Class I
EU06956382439263Class I
EU06956382439256Class I
EU06956382439249Class I
UK35492Disposable isolation gownClass I
UK32297Disposable Surgical CapClass I
UK65414Disposable Surgical CoverallClass I
USK202903Surgical Face Mask2022-03-24

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