HomeChinaHangzhou Sunstone Technology Co.,LTD

Hangzhou Sunstone Technology Co.,LTD

China · 杭州 · www.hzsskj.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000040501Unified social credit code 91330101782360325W

This company holds 7 NMPA certificates in China and has registrations in European Union, United States, South Korea — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
7China registrations
Class II 4Class III 3
as of 2026-09-04
EUEuropean UnionEUDAMED
42UDI-DI device records
Class I 12Class IIb 30
USUnited StatesFDA openFDA
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 0 510(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
2GMP quality-system certificates
Import 2
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 Union42 raw hits, 0 excluded, 42 confirmed
United States1 registration records, 0 510(k), 0 PMA
China7 certificates (Class III 3 / II 4 / I 0), as of 2026-09-04
Manufacturer names merged into this page: HANGZHOU SUNSTONE TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000040501
EU authorised representative
MedPath GmbH
Unified social credit code
91330101782360325W
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
67
Website
www.hzsskj.com
Product categories
手术器械

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
2005-11-28
Registered capital
CNY 34,445,400
Paid-in capital
CNY 34,445,400
Legal form
Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2024-11-22
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SMEInnovative SME

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 listed device types

Applier, Hemostatic Clip 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20243020743一次性使用连发结扎夹Class III
CN国械注准20223021477一次性使用闭合夹Class III
CN国械注准20163020594可吸收止血结扎夹Class III
CN浙械注准20242021498连发施夹钳Class II
EU06951360201276Multiple Polymer Ligating ClipsClass IIb
EU06951360201269Multiple Polymer Ligating ClipsClass IIb
EU06951360201252Multiple Polymer Ligating ClipsClass IIb
EU06951360201245Multiple Clip Reusable ApplierClass I

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