Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007327621

FEI Number

3007327621

Entity Name

BIOREGEN BIOMEDICAL (CHANGZHOU) CO., LTD

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

Building B, No. 117, Xueye Road, Changzhou Jiangsu 213125, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

BioRegen Biomedical (Changzhou) Co., Ltd (Owner Number: 10027304)

Owner / Operator Contact Address

Building B, No. 117, Xueye Road, Changzhou, CN-JS 213125, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PureRegen Gel Sinus HealoRegen Gel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2008-10-23
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2015-05-11

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

BioRegen Biomedical (Changzhou) Co., Ltd

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007327621. Last updated year: 2026. Please use registration number 3007327621 when referencing this establishment in official correspondence.