Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014247261

FEI Number

3014247261

Entity Name

HANGZHOU BRONCUS MEDICAL CO., LTD.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

Room 105-136, 1/F, Building 2, No.88 Jiangling Road, Xixing Street, Binjiang District, Hangzhou Zhejiang 310051, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Hangzhou Broncus Medical Co., Ltd. (Owner Number: 10083430)

Owner / Operator Contact Address

Room 105-136, 1/F, Building 2, No.88 Jiangling Road, Xixing Street, Binjiang District, Hangzhou, CN-ZJ 310051, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FleXNeedle BioStar® Transbronchial Aspiration Needle BroncTru Transbronchial Access Tool

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2025-09-17
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-12-02
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-12-02

Official Correspondent

Mei Liu

US Agent Details

Antoinette Clay Email: aclay@broncus.com Phone: (650) 4281600

Related Public Records

Same Entity

Hangzhou Broncus Medical Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

Similar Registrations

Registration Number	Establishment Name	Location
3004065885	Creation Technologies	Everett, WA, US
3005099803	BOSTON SCIENTIFIC CORPORATION	Marlborough, MA, US
8010047	OLYMPUS MEDICAL SYSTEMS CORP.	HACHIOJI-SHI Tokyo, JP
3015970743	CENTERPOINT SYSTEMS LLC	West Valley City, UT, US
3008729892	MEDIPLAST ISRAEL LTD	Yavne Tel Aviv, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014247261. Last updated year: 2026. Please use registration number 3014247261 when referencing this establishment in official correspondence.