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BrosMed Medical Co., Ltd.

✓ Record-verifiedregistrations found in 12 marketsEU SRN CN-MF-000007501Unified social credit code 91441900590137612T

This company holds 28 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 overseas markets. EU UDI-DI records ≥100, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

28China registrations

Class II 4Class III 24

as of 2026-09-04

EUEuropean UnionEUDAMED

≥100UDI-DI device records

Class IIa 100

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

USUnited StatesFDA openFDA

4listed device types

Class I 0Class II 4Class III 0

plus 22 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

26registered device records

Class I 5Class IIa 13Class III 8

BRBrazilANVISA

81registered devices

Class I 10Class II 71

90 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

15valid device licences

Class II 13Class III 2

SGSingaporeHSA SMDR

7device registrations

CLASS B 3CLASS D 4

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Business type not stated 1Import 3

AUAustraliaTGA ARTG

10active ARTG entries

Class III 3IIa 4Class Is (sterile) 3

HKHong KongMDACS

5valid listings

Class IV 5

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

2active registrations

Class 3 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 Union11,083 raw hits, 0 excluded, 100 confirmed. Large result set — only the first 300 verified

United States22 registration records, 10 510(k), 0 PMA

China28 certificates (Class III 24 / II 4 / I 0), as of 2026-09-04

United Kingdom26 confirmed, 0 excluded

Brazil81 confirmed, 0 excluded

Manufacturer names merged into this page: BROSMED MEDICAL (MALAYSIA) SDN. BHD. · BROSMED MEDICAL CO.,LTD · BROSMED MEDICAL CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000007501
EU authorised representative: Brosmed Medical B.V.
UK responsible person: Advena Ltd
Unified social credit code: 91441900590137612T
Exhibition record: CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2012-03-01
Registered capital: CNY 57,820,355
Paid-in capital: CNY 18,661,588
Legal form: Joint-stock limited company
Industry classification: Pharmaceutical manufacturing
Last approval date: 2025-06-05
Recognitions: National High-Tech EnterpriseTechnology-based SMENational SRDI "Little Giant"SRDI SMEGazelle enterpriseAbove-designated-size industrial enterprise

Business registration data from Tianyancha, as of 2026-09-03. 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.

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263030198	封堵球囊导管套件	Class III
CN	国械注准20243032575	冠状动脉高压切割球囊导管	Class III
CN	国械注准20243032570	微导管	Class III
CN	国械注准20243032290	颈动脉球囊扩张导管	Class III
EU	06958481467628	Tri-Wedge	Class IIa
EU	06958481467536	Tri-Wedge	Class IIa
EU	06958481466843	Tri-Wedge	Class IIa
EU	06958481466775	Tri-Wedge	Class IIa
UK	15286	Angiographic Syringe and Accessories	Class IIa
UK	35094	Conger Hydrophilic Guidewires	Class IIa
UK	35094	Eagle Guidewires	Class III
US	K243704	Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter	2025-02-27
US	K241478	Tri-Wedge PTA Scoring Balloon Dilatation Catheter	2024-10-22
US	K230705	POT PTCA Balloon Dilatation Catheter	2023-04-11
BR	81582089024	KIT BAINHA DE INTRODUTOR RADIAL	Class II
BR	81582089025	FIO GUIA CONGER	Class II
BR	81582089026	INSUFLADOR DE CATETER BALÃO	Class II

BrosMed Medical 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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