Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007127244

FEI Number

3007127244

Entity Name

TAIWAN ADVANCED STERILIZATION TECHNOLOGY INC.

City/State/Country

Taichung County, TW

Establishment Address

Taichung Export Processing Zone, No. 17-1 Chien Kuo Rd. Tan Tze, Taichung County 427, TW

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Taiwan Advanced Sterilization Technology Inc. (Owner Number: 10026550)

Owner / Operator Contact Address

Taichung Export Processing Zone, #17-1 Chien Kuo Rd. Tan Tze, Taichung County, TW-TXG 427, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Uro-N Cystoscope Uro-V Cystoscope lioli IOL Delivery System BL-Cart IOL Delivery Cartridge bioli IOL Delivery System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-04-08
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-04-08
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2015-11-25
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2019-10-28
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2020-07-05

Official Correspondent

Jack Wu

US Agent Details

Emily Matorin Business: FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

Taiwan Advanced Sterilization Technology Inc.

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 3007127244. Last updated year: 2026. Please use registration number 3007127244 when referencing this establishment in official correspondence.