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Jiangsu Kangjin Medical Instrument Co., Ltd.

China · Changzhou Jiangsu · www.kangjin.cn

✓ Record-verifiedregistrations found in 11 marketsEU SRN CN-MF-000011142Unified social credit code 91320402251025560Y

This company holds 58 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 10 overseas markets.

Registrations by market

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

CNChinaNMPA

58China registrations

Class I 6Class II 24Class III 28

as of 2026-09-04

EUEuropean UnionEUDAMED

224UDI-DI device records

Class I 142Class IIa 79Class IIb 3

USUnited StatesFDA openFDA

13listed device types

Class I 9Class II 4Class III 0

plus 12 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

16registered device records

Class I 8Class IIa 6Class IIb 2

BRBrazilANVISA

14registered devices

Class I 12Class II 2

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

3valid device licences

Class I 3

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

9active ARTG entries

Class I 3IIa 4Class Is (sterile) 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 4

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 Union276 raw hits, 52 excluded, 224 confirmed

United States12 registration records, 0 510(k), 0 PMA

China58 certificates (Class III 28 / II 24 / I 6), as of 2026-09-04

United Kingdom16 confirmed, 2 excluded

Brazil14 confirmed, 0 excluded

Manufacturer names merged into this page: JIANGSU KANGJIN MEDICAL INSTRUMENT CO.,LTD. · JIANGSU KANGJIN MEDICAL INSTRUMENT CO., LTD. · JIANGSU KANGJIN MEDICAL INSTRUMENT CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000011142
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: SUNGO Certification Company Limited
Unified social credit code: 91320402251025560Y
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 1999-04-12
Registered capital: CNY 60,000,000
Paid-in capital: CNY 16,000,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Pharmaceutical manufacturing
Last approval date: 2025-11-28
Recognitions: National High-Tech EnterprisePrivate technology 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 listed device types

showing 8 of 13

Forceps, Biopsy, Non-Electric 1Accessories, Cleaning Brushes, For Endoscope 1Instrument, Surgical, Disposable 1Snare, Non-Electrical 1Gag, Mouth 1Enema Kit 1Accessories, Catheter 1Bag, Urine Collection, Leg, For External Use, Non-Sterile 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20243142438	一次性使用泵用注射器	Class III
CN	国械注准20243142001	一次性使用泵用输液器	Class III
CN	国械注准20233141879	一次性使用避光压力延长管	Class III
CN	国械注准20233141871	一次性使用精密过滤泵用输液器	Class III
EU	06942231607815	Collection Bag for Single Use	Class I
EU	16942231631589	SUPPORTI PER BORSE URINA	Class I
EU	06942231699995	Bolsa de Orina	Class I
EU	26942231631289	Bolsa Orina Pierna	Class I
UK	61455	Electrosurgical Snares for Single Use	Class IIb
UK	61455	Hot biopsy forceps for single use	Class IIa
UK	64461	Enteral feeding set for single use	Class IIa
BR	82517920002	Mouth Guards for Single Use - Bocal para Endoscopia	Class I
BR	82316950008	Bolsa Coletora de Urina - Sistema Fechado	Class I
BR	80633660003	Mouth Guards for single use ( Bocal para Endoscopia)	Class I