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ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO., LTD

China · 湖州

✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000025970Unified social credit code 9133052369951352X9

This company holds 13 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, South Korea, Australia, Israel — 8 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

13China registrations

Class II 7Class III 2

as of 2026-09-04

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class I 4Class IIb 296

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

13listed device types

Class I 7Class II 6Class III 0

plus 18 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

5registered device records

Class IIa 1Class IIb 4

BRBrazilANVISA

3registered devices

Class II 3

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

2 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

14active ARTG entries

IIb 11Class Is (sterile) 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 Union332 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States18 registration records, 1 510(k), 0 PMA, 3 excluded

China13 certificates (Class III 2 / II 7 / I 0), as of 2026-09-04

United Kingdom5 confirmed, 0 excluded

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: Zhejiang Shuyou Surgical Instrument Co., Ltd · ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO., LTD. · ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000025970
EU authorised representative: Luxus Lebenswelt GmbH
UK responsible person: KINGSMEAD SERVICE LIMITED
Unified social credit code: 9133052369951352X9
Exhibition record: CMEF 89th (Apr 2024, Shanghai)

Business registration

Registration status: Active
Incorporated: 2009-12-29
Registered capital: CNY 30,000,000
Paid-in capital: CNY 30,000,000
Legal form: Joint-stock limited company (unlisted)
Industry classification: Technology promotion and application services
Last approval date: 2020-08-20
Recognitions: National High-Tech EnterpriseTorch Programme enterpriseAbove-designated-size industrial enterprise
Listing: Listed on the NEEQListed on a regional equity market

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 · K260466

FDA listed device types

showing 8 of 13

Electrosurgical, Cutting & Coagulation & Accessories 1Electrosurgical Patient Return Electrode 1Electrocautery, Gynecologic (And Accessories) 1Curette, Suction, Endometrial (And Accessories) 1Apparatus, Exhaust, Surgical 1Tenaculum, Uterine, Exempt 1Sound, Uterine 1Tubing/Tubing With Filter, Insufflation, Laparoscopic 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20233011963	高频手术设备	Class III
CN	国械注准20203010500	一次性使用电凝切割器	Class III
CN	浙械注准20242011093	一次性使用高频电刀笔	Class II
CN	浙械注准20182020247	一次性使用冲洗吸引器	Class II
EU	06924274955900	Multifunctional Operational Dissectors（Electrosurgical pencils）	Class IIb
EU	06924274955955	Multifunctional Operational Dissectors（Electrosurgical pencils）	Class IIb
EU	06924274956006	Multifunctional Operational Dissectors（Electrosurgical pencils）	Class IIb
EU	06924274956051	Multifunctional Operational Dissectors（Electrosurgical pencils）	Class IIb
UK	58494	Disposable electrosurgical pads	Class IIb
UK	11490	High Frequency Electrosurgical Generators	Class IIb
UK	61874	Disposable Electrodes	Class IIb
US	K260466	Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)	2026-04-07
BR	80082910202	EQUIPO PARA IRRIGAÇÃO EM GINECOLOGIA TAIMIN	Class II
BR	80082910203	EQUIPO PARA IRRIGAÇÃO EM GINECOLOGIA E UROLOGIA TAIMIN	Class II
BR	80082910204	EQUIPO DE IRRIGAÇÃO PARA ARTROSCOPIA TAIMIN	Class II

ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO., LTD

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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