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Zhejiang Soudon Medical Technology Co.,ltd

✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000021047Unified social credit code 91330110MA2KCFDJ38

This company holds 18 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, South Korea, Australia, Israel — 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

18China registrations

Class II 12Class III 6

as of 2026-09-04

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class I 45Class IIa 165Class IIb 90

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

USUnited StatesFDA openFDA

9listed device types

Class I 3Class II 6Class III 0

plus 9 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

6registered device records

Class I 2Class IIa 2Class IIb 2

BRBrazilANVISA

14registered devices

Class I 1Class II 13

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

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 Union470 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States9 registration records, 5 510(k), 0 PMA

China18 certificates (Class III 6 / II 12 / I 0), as of 2026-09-04

United Kingdom6 confirmed, 0 excluded

Brazil14 confirmed, 0 excluded

Manufacturer names merged into this page: ZHEJIANG SOUDON MEDICAL TECHNOLOGY CO.,LTD · ZHEJIANG SOUDON MEDICAL TECHNOLOGY CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000021047
EU authorised representative: Luxus Lebenswelt GmbH
UK responsible person: Crown Medical Supplies Limited
Unified social credit code: 91330110MA2KCFDJ38
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Business registration

Registration status: Active
Incorporated: 2020-12-10
Registered capital: CNY 50,000,000
Paid-in capital: CNY 46,480,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Pharmaceutical manufacturing
Last approval date: 2026-08-07
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseFledgling 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

22023 · K232442

12024 · K232450

22026 · K253013

FDA listed device types

showing 8 of 9

Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection 1Endoscopic Injection Needle, Gastroenterology-Urology 1Endoscopic Guidewire, Gastroenterology-Urology 1Dislodger, Stone, Biliary 1Unit, Electrosurgical, Endoscopic (With Or Without Accessories) 1Hemostatic Metal Clip For The Gi Tract 1Forceps, Biopsy, Non-Electric 1Accessories, Cleaning Brushes, For Endoscope 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20233140132	一次性使用内窥镜注射针	Class III
CN	国械注准20233011271	一次性使用高频切开刀	Class III
CN	国械注准20233011023	一次性使用十二指肠乳头切开刀	Class III
CN	国械注准20233010679	一次性使用热活检钳	Class III
EU	06975137041971	Disposable Hemostatic Clips	Class IIb
EU	06975137041988	Disposable Hemostatic Clips	Class IIb
EU	06975137041995	Disposable Hemostatic Clips	Class IIb
EU	06975137042008	Disposable Hemostatic Clips	Class IIb
UK	61950	Bite Block	Class I
UK	61950	Disposable Cleaning Brush	Class I
UK	38711	Disposable Biopsy Forceps	Class IIa
US	K253013	Disposable Stone Retrieval Balloon Catheter	2026-05-08
US	K253056	Disposable Stone Extraction Basket	2026-04-03
US	K232450	Disposable Hemostatic Clips	2024-01-26
BR	81040539015	Agulha de biópsia para ultrassom endoscópico - Soudon	Class II
BR	82003529001	Pinça de Biópsia Descartável	Class II
BR	82003529004	Pinça de Apreensão Descartável	Class II

Zhejiang Soudon Medical Technology 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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