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Broncus Medical, Inc.

USA · San Jose

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Hong Kong, Israel — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 3Class III 0

plus 12 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

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

5 including historic records

TWTaiwanTFDA

4valid device licences

Class II 4

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

4valid listings

Class II 4

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 States12 registration records, 7 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: Broncus Medical Inc · HANGZHOU BRONCUS MEDICAL CO., LTD. · BRONCUS MEDICAL, INC.

FDA 510(k) clearances by year

12013 · K131234

12014 · K133385

12019 · K183240

12021 · K200702

22024 · K232601

12026 · K260009

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1System, Image Processing, Radiological 1Bronchoscope (Flexible Or Rigid) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260009	LungPoint Virtual Bronchoscopic Navigation (VBN) Software	2026-04-24
US	K232601	BroncTru Transbronchial Access Tool	2024-05-31
US	K232038	BioStar Single Use Transbronchial Aspiration Needle	2024-04-26

Broncus Medical, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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