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Shanghai INT Medical Instruments Co., Ltd

✓ Record-verifiedregistrations found in 10 marketsUnified social credit code 913100007895295174

This company holds 65 NMPA certificates in China and has registrations in United States, United Kingdom, Brazil, Taiwan, South Korea, Australia, Hong Kong, Israel, Russia — 9 overseas markets.

Registrations by market

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

CNChinaNMPA

65China registrations

Class II 35Class III 30

as of 2026-09-04

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

11listed device types

Class I 2Class II 9Class III 0

plus 15 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

22registered device records

Class I 7Class IIa 13IVD general 2

BRBrazilANVISA

23registered devices

Class I 2Class II 21

28 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

10valid device licences

Class II 10

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

11active ARTG entries

Class I 1IIa 9Class Is (sterile) 1

HKHong KongMDACS

6valid listings

Class II 5Class IV 1

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

3active registrations

Class 3 3

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 Union272,235 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States15 registration records, 2 510(k), 0 PMA, 54 excluded

China65 certificates (Class III 30 / II 35 / I 0), as of 2026-09-04

United Kingdom22 confirmed, 437 excluded

Brazil23 confirmed, 1 excluded

Saudi Arabia0 confirmed, 3 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: Shanghai INT Medical Instruments Co., Ltd. · SHANDONG INT MEDICAL INSTRUMENTS CO., LTD · SHANGHAI INT MEDICAL INSTRUMENTS CO.,LTD.

Regulatory identity

UK responsible person: MDQ Services Ltd
Unified social credit code: 913100007895295174
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2006-06-07
Registered capital: CNY 211,200,000
Paid-in capital: CNY 18,300,001
Legal form: Joint-stock limited company (listed)
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2026-01-23
Recognitions: National High-Tech EnterpriseSRDI SMETechnology "Little Giant"Above-designated-size industrial enterprise
Listing: Listed in Hong Kong

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

12024 · K242143

12025 · K244038

FDA listed device types

showing 8 of 11

Introducer, Catheter 1Wire, Guide, Catheter, Exempt 1Trocar 1Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 1Injector And Syringe, Angiographic 1Syringe, Balloon Inflation, Exempt 1Percutaneous Sheath Introducer Kit 1Angiography/Angioplasty Kit 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263030185	冠状动脉高压球囊扩张导管	Class III
CN	国械注准20263030014	血栓抽吸导管及附件	Class III
CN	国械注准20253030739	微导管	Class III
CN	国械注准20243142420	一次性使用输液装置	Class III
UK	62981	Combined isothermal bag for blood components transport - LARGE	Class IIa
UK	62981	Combined isothermal bag for blood components transport (12 hours) – SMALL	Class I
UK	57952	Polycarbonate secondary container for biological samples transport - SMALL	IVD general
US	K244038	High Pressure Tubing	2025-09-05
US	K242143	Angiography Injector	2024-12-23
BR	81231559037	Conector em Y	Class II
BR	81231550065	Cateter Diagnóstico Centimetrado Total Life	Class II
BR	81231550011	Fio Guia Teflonado Total Life.	Class II