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Changzhou Waston Medical Appliance Co., Ltd.

China · 常州

✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000004851Unified social credit code 91320412735743809M

This company holds 146 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Australia, Israel, Russia — 7 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

146China registrations

Class I 64Class II 49Class III 33

as of 2026-09-04

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class I 198Class IIa 17Class IIb 85

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

USUnited StatesFDA openFDA

5510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

5registered device records

Class IIb 5

BRBrazilANVISA

5registered devices

Class I 4Class II 1

7 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 1IIb 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

2active registrations

Class 2b 2

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 Union1,586 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States0 registration records, 5 510(k), 0 PMA

China146 certificates (Class III 33 / II 49 / I 64), as of 2026-09-04

United Kingdom5 confirmed, 0 excluded

Brazil5 confirmed, 0 excluded

Manufacturer names merged into this page: CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000004851
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: SUNGO Certification Company Limited
Unified social credit code: 91320412735743809M
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2002-04-17
Registered capital: CNY 167,330,000
Paid-in capital: CNY 167,330,000
Legal form: Joint-stock limited company (foreign-invested)
Industry classification: Pharmaceutical manufacturing
Last approval date: 2025-06-10
Recognitions: National High-Tech EnterprisePrivate technology enterpriseSRDI SMEGazelle enterpriseTorch Programme 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.

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263131113	不可吸收韧带固定螺钉	Class III
CN	国械注准20253172539	正畸支抗钉	Class III
CN	国械注准20253172318	牙科种植体基台及附件	Class III
CN	国械注准20253131607	锁定接骨板	Class III
EU	06936594497282	TOP STAPLER	Class IIb
EU	06936594492706	Disposable Linear Cutter	Class IIb
EU	06936594499194	Cartridge for Disposable Endoscopic Cutter Stapler	Class IIb
EU	06936594492713	Disposable Linear Cutter	Class IIb
UK	59871	Disposable Endoscopic Cutter Stapler and Cartridges	Class IIb
UK	59874	EHMS Endoscopic Hernia Multifeed Stapler	Class IIb
UK	46737	Disposable PPH Stapler	Class IIb
US	K211197	Disposable Endoscopic Cutter Stapler and Cartridge	2023-01-19
US	K151062	WASTON Metallic Intramedullary Nail System	2015-12-17
US	K150684	WASTON General Spinal System	2015-11-18
BR	81504790552	Sistema de Instrumentos para Trauma	Class I
BR	81504799193	Trocarte descartável	Class II
BR	81504790519	Sistema de Instrumentos Torácicos	Class I

Changzhou Waston Medical Appliance Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

Registration details (sample)

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