Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026035667

FEI Number

3026035667

Entity Name

RELAJET TECH (TAIWAN) CO., LTD.

City/State/Country

Taipei, TW

Establishment Address

8F., No. 150, Sec. 4, Nanjing E. Rd., Songshan Dist., Taipei 105, TW

Establishment Type(s)

Foreign Private Label Distributor,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

RelaJet Tech (Taiwan) Co., Ltd. (Owner Number: 10086633)

Owner / Operator Contact Address

4F., No. 133, Sec. 4, Mingsheng E. Rd., Songshan Dist., Taipei, TW-TPE 105412, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RelaJet Tech Hearing Aid HEB-003 RelaJet Tech Hearing Aid HFE-001 Otoadd F1 Hearing Aid

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2023-05-11

Official Correspondent

Alan Yen

US Agent Details

Ho Shan Wang Email: acmebiotechs@gmail.com Phone: (623) 9864377

Related Public Records

Same Entity

RelaJet Tech (Taiwan) 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 3026035667. Last updated year: 2026. Please use registration number 3026035667 when referencing this establishment in official correspondence.