Home›China›Jiangxi Hongda Medical Equipment Group Ltd

Jiangxi Hongda Medical Equipment Group Ltd

China · Nanchang Jiangxi · www.jxhd.cn

✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000006019Unified social credit code 9136012474429059X9

This company holds 119 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Singapore, Australia, Hong Kong, Israel, Russia — 9 overseas markets. EU UDI-DI records ≥299, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

119China registrations

Class I 11Class II 54Class III 54

as of 2026-09-04

EUEuropean UnionEUDAMED

≥299UDI-DI device records

Class I 22Class IIa 142Class IIb 133IVD A 2

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

USUnited StatesFDA openFDA

8listed device types

Class I 3Class II 5Class III 0

plus 8 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

3registered device records

Class IIa 3

BRBrazilANVISA

64registered devices

Class I 13Class II 51

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

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

8active ARTG entries

Class I 1IIa 6IIb 1

HKHong KongMDACS

3valid listings

Class II 3

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

11active registrations

Class 1 1Class 2a 8Class 2b 1Class 3 1

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 Union434 raw hits, 1 excluded, 299 confirmed. Large result set — only the first 300 verified

United States8 registration records, 7 510(k), 0 PMA, 1 excluded

China119 certificates (Class III 54 / II 54 / I 11), as of 2026-09-04

United Kingdom3 confirmed, 0 excluded

Brazil64 confirmed, 0 excluded

Manufacturer names merged into this page: JIANGXI HONGDA MEDICAL EQUIPMENT GROUP LTD. · JIANGXI HONGDA MEDICAL EQUIPAMENT GROUP LTD. · JIANGXI HONGDA MEDICAL EQUIPMENT GROUP LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000006019
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: RPG Medical Limited
Unified social credit code: 9136012474429059X9
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 1999-07-01
Registered capital: CNY 428,880,000
Paid-in capital: CNY 392,690,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Pharmaceutical manufacturing
Last approval date: 2025-12-29
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseRecognised enterprise technology centre

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

32017 · K163160

42021 · K211753

FDA listed device types

Vinyl Patient Examination Glove 1Polymer Patient Examination Glove 1Non-Surgical Gown 1Syringe, Piston 1Syringe, Antistick 1Mask, Surgical 1Set, Administration, Intravascular 1Needle, Hypodermic, Single Lumen 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263141076	一次性使用无针输液接头	Class III
CN	国械注准20263140982	一次性使用无菌避光注射器带针	Class III
CN	国械注准20253140270	一次性使用避光静脉留置针	Class III
CN	国械注准20243102589	一次性使用动静脉穿刺针	Class III
EU	66920756710144	Syringes for single use	Class IIa
EU	66920756710489	Syringes for single use	Class IIa
EU	66920756718591	Hollow fiber hemodialyzer low-flux	Class IIb
EU	66920756718584	Hollow fiber hemodialyzer low-flux	Class IIb
UK	12170	EZ-IV	Class IIa
UK	58977	EZ-IV	Class IIa
UK	38569	EZ-IV	Class IIa
US	K211753	Sterile Syringe With Safety Needle	2021-10-14
US	K210622	Single-Use Medical Face Mask	2021-10-08
US	K210578	Medical Nitrile Examination Gloves (Power free, Blue)	2021-07-10
BR	82942919006	AGULHA MÚLTIPLA PARA COLETA À VÁCUO TERA	Class II
BR	82942919007	ESCALPE PARA COLETA DE SANGUE À VÁCUO TERA	Class II
BR	80263409036	Equipo de Nutrição Enteral RMDESC	Class II