Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016931787

FEI Number

3016931787

Entity Name

BRUN MEDICAL CO., LTD.

City/State/Country

Zhuzhou Hunan, CN

Establishment Address

Building B8, Entrepreneurship and Innovation Park, 88 Changtang Road, Yunlong Demonstration Zone, Zhuzhou Hunan 412000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Brun Medical Co., Ltd. (Owner Number: 10068588)

Owner / Operator Contact Address

Building B8, Entrepreneurship and Innovation Park, 88 Changtang Road, Yunlong Demonstration Zone, Zhuzhou, CN-HN 412000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Balloon Inflation Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2026-04-29

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Brun Medical Co., Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016931787. Last updated year: 2026. Please use registration number 3016931787 when referencing this establishment in official correspondence.