Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033919393

FEI Number

3033919393

Entity Name

INTEGRAL STERILIZATION TECHNOLOGY (SHAOXING) CO., LTD

City/State/Country

Shaoxing Zhejiang, CN

Establishment Address

3F and 4F, Building 3, No. 77, Zhongshan Road, Gaobu Town, Shaoxing Zhejiang 312000, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Integral Sterilization Technology (Shaoxing) Co., Ltd (Owner Number: 10091961)

Owner / Operator Contact Address

3F and 4F, Building 3, No. 77, Zhongshan Road, Gaobu Town, Shaoxing, CN-ZJ 312000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cure Catheter Extension Tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNZ	System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2024-11-20

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

Integral Sterilization Technology (Shaoxing) 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 3033919393. Last updated year: 2026. Please use registration number 3033919393 when referencing this establishment in official correspondence.