GIGATEK INC.

FDA Device Registration & Listing · Taichung, TW · Registration 3002686300

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3002686300
FEI Number
3002686300
Entity Name
GIGATEK INC.
City/State/Country
Taichung, TW
Establishment Address
No. 47, Xianghe Rd., Tanzi Dist., Taichung City, Taichung 42741, TW
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
GIGATEK INC. (Owner Number: 10086845)
Owner / Operator Contact Address
No. 47, Xianghe Rd., Tanzi Dist., Taichung City, Taichung, TW-TXG 42741, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KLW Masker, Tinnitus Ear, Nose, Throat Class 2 874.3400 2026-02-09
OSM Hearing Aid, Air-Conduction With Wireless Technology, Prescription Ear, Nose, Throat Class 2 874.3305 2026-02-10

Official Correspondent

CHIH-CHUAN CHEN

US Agent Details

JAMES SCHWARZ Email: jim@intersphereindustries.com Phone: (847) 6876522

Related Public Records

Same Entity

GIGATEK INC.
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 3002686300. Last updated year: 2026. Please use registration number 3002686300 when referencing this establishment in official correspondence.
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