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Zhonghong Pulin Medical Products Co., Ltd.

✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000001108Unified social credit code 911302005661986189

This company holds 6 NMPA certificates in China and has registrations in European Union, United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Israel, Russia — 9 overseas markets.

Registrations by market

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

CNChinaNMPA

6China registrations

Class I 6

as of 2026-09-04

EUEuropean UnionEUDAMED

80UDI-DI device records

Class I 80

USUnited StatesFDA openFDA

5listed device types

Class I 5Class II 0Class III 0

plus 10 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

8registered devices

Class I 8

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

7registered imported devices

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

CACanadaMDALL

0active device licences

5 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

8active ARTG entries

Class I 8

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

9registrations

RURussiaRoszdravnadzor

2active registrations

Class 1 2

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 Union80 raw hits, 0 excluded, 80 confirmed

United States10 registration records, 13 510(k), 0 PMA

China6 certificates (Class III 0 / II 0 / I 6), as of 2026-09-04

Brazil8 confirmed, 0 excluded

Saudi Arabia7 confirmed, 0 excluded

Manufacturer names merged into this page: ZHONGHONG PULIN MEDICAL PRODUCTS CO.,LTD. · JIANGXI ZHONGHONG PULIN MEDICAL PRODUCTS CO.,LTD. · ZHONGHONG PULIN MEDICAL PRODUCTS CO., LTD. · JIANGXI ZHONGHONG PULIN MEDICAL PRODUCTS CO., LTD. · JIANGXI ZHONGHONG PULIN MEDICAL PRODUCTS CO. LTD · Zhonghong Pulin Medical Products Co.,Ltd

Regulatory identity

EU manufacturer SRN: CN-MF-000001108
EU authorised representative: Continental Medical B.V.
Unified social credit code: 911302005661986189
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2010-12-22
Registered capital: CNY 428,864,959
Paid-in capital: CNY 428,864,959
Legal form: Joint-stock limited company (listed, state-controlled)
Industry classification: Rubber and plastic products
Last approval date: 2025-09-30
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMEAbove-designated-size industrial enterprise
Listing: Listed on the A-share marketDelisted from the NEEQ

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

22002

12009

22012

12016

12017

12018

22021

12022

22023

FDA listed device types

Fentanyl And Other Opioid Protection Glove 1Vinyl Patient Examination Glove 1Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs 1Polymer Patient Examination Glove 1Medical Glove, Specialty 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	冀唐械备20210004号	医用检查手套	Class I
CN	冀唐械备20170028号	医用检查手套	Class I
CN	冀唐械备20170027号	医用检查手套	Class I
CN	冀唐械备20150016号	医用检查手套	Class I
EU	02400000135661	Disposable examination and protective nitrile gloves KORAKO MEDICAL	Class I
EU	02400000042259	Disposable examination and protective nitrile gloves KORAKO MEDICAL	Class I
EU	02400000042242	Disposable examination and protective nitrile gloves KORAKO MEDICAL	Class I
EU	02400000042235	Disposable examination and protective nitrile gloves KORAKO MEDICAL	Class I
US	K231029	Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl	2023-10-30
US	K230662	Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs	2023-10-26
US	K222534	Nitrile Patient Examination Glove	2022-11-23
BR	81818100010	luva nitrílica	Class I
BR	81818100016	Luva Vinil Sem Pó	Class I
BR	81818100016	Luva Vinil Sem Pó	Class I
SA	ME0000012953SFDAA00001	Powder Free Vinyl Examination Gloves	—
SA	ME0000012953SFDAA00002	U2 Disposable Vinyl Gloves	—

Zhonghong Pulin Medical Products 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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