Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011489270

FEI Number

3011489270

Entity Name

HIERAX ENTERPRISE CO., LTD

City/State/Country

TAICHUNG CITY, TW

Establishment Address

NO. 12, LN. 67, TAIMING RD., WURI DIST.,, TAICHUNG CITY 41468, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HIERAX ENTERPRISE CO., LTD (Owner Number: 10083069)

Owner / Operator Contact Address

NO. 12, LN. 67, TAIMING RD., WURI DIST.,, TAICHUNG CITY, TW-TXG 41468, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Peristeen Plus tubes Peristeen System without Catheters Peristeen Plus System without Catheters(excl toilet bag) Peristeen Plus System without Catheters(Incl toilet bag) Peristeen Tubes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FCE	Enema Kit	Gastroenterology, Urology	Class 1	876.5210	2021-10-22

Official Correspondent

No official correspondent registered.

US Agent Details

Manoj Zacharias Business: Liberty Management Group Ltd. Email: office@libertymanagement.us Phone: (630) 2702921

Related Public Records

Same Entity

HIERAX ENTERPRISE CO., LTD

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3038700860	DavisDuhs, LLC	Auburn, CA, US
3014615175	K-MED CO., LTD.	Yangzhou Jiangsu, CN
3011919098	NINGBO JUST SOON INDUSTRIAL LIMITED	Ningbo Zhejiang, CN
1921846	Cardinal Health	Hazelwood, MO, US
3005669815	AMSINO MEDICAL (KUNSHAN) CO., LTD.	KUNSHAN CITY Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011489270. Last updated year: 2026. Please use registration number 3011489270 when referencing this establishment in official correspondence.