HomeChinaKunshan Jiehong Nonwoven Product Co., Ltd.

Kunshan Jiehong Nonwoven Product Co., Ltd.

China · Kunshan Jiangsu · www.jiehongmedical.cn
✓ Record-verifiedregistrations found in 4 marketsUnified social credit code 91320583754603019M

This company holds 24 NMPA certificates in China and has registrations in United States, Australia, Israel — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
24China registrations
Class I 13Class II 11
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
15listed device types
Class I 11Class II 4Class III 0
plus 32 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
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
pendingnot queried
AUAustraliaTGA ARTG
10active ARTG entries
Class I 7Class Is (sterile) 3
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.

United States32 registration records, 2 510(k), 0 PMA, 1 excluded
China24 certificates (Class III 0 / II 11 / I 13), as of 2026-09-04
Manufacturer names merged into this page: KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD. · FENGYANG JIEHONG NONWOVEN PRODUCT CO., LTD. · JIEHONG NONWOVEN PRODUCTS(BD) CO.,LTD

Regulatory identity

Unified social credit code
91320583754603019M
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Kunshan Jiangsu
Social-insurance enrolees
118
Annual revenue
over RMB 500M
Website
www.jiehongmedical.cn
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2003-10-16
Registered capital
CNY 26,445,628
Paid-in capital
CNY 26,445,628
Legal form
Limited liability company
Industry classification
Non-metallic mineral products
Last approval date
2026-03-23
Recognitions
Micro and small enterpriseNational High-Tech 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

22011 · K112136

FDA listed device types

showing 8 of 15
Cap, Surgical 1Dress, Surgical 1Support, Patient Position 1Accessory, Surgical Apparel 1Gown, Examination 1Non-Surgical Gown 1Suit, Surgical 1Cover, Shoe, Operating-Room 1

Registration details (sample)

MarketIdentifierNameClass / date
CN苏械注准20252140741手术膜Class II
CN苏械注准20252140684一次性使用无菌保护罩Class II
CN苏械注准20222141722重复用手术单Class II
CN苏械注准20222141719可重复使用手术衣Class II
USK112136TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE2011-09-29
USK111067JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE2011-08-02

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