Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3040279031

FEI Number

3040279031

Entity Name

AEGIS (TAIWAN) BIOPHARMACEUTICALS INC.

City/State/Country

Taichung City, TW

Establishment Address

1F., No. 141-1, Sec. 1, Dalian Rd., Beitun Dist., Taichung City 406044, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Aegis (Taiwan) Biopharmaceuticals Inc. (Owner Number: 10093839)

Owner / Operator Contact Address

1F., No. 141-1, Sec. 1, Dalian Rd., Beitun Dist., Taichung City, TW-TXG 406044, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Epiatrix Wound Dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2025-07-21

Official Correspondent

ViVi Yeh

US Agent Details

Chun-Kai Yang Email: ra733015@gmail.com Phone: (580) 8780111

Related Public Records

Same Entity

Aegis (Taiwan) Biopharmaceuticals 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 3040279031. Last updated year: 2026. Please use registration number 3040279031 when referencing this establishment in official correspondence.