Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006011998

FEI Number

3006011998

Entity Name

MAINTEK COMPUTER (SUZHOU) CO.,LTD.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No. 233, Jinfeng Road, Suzhou Jiangsu 215011, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Pegatron Corporation (Owner Number: 10079441)

Owner / Operator Contact Address

No. 76, Ligong St., Beitou District,, Taipei, TW-NOTA 112, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Eargo 6 Eargo 7 Eargo 5 Eargo SE Eargo 8

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QUH	Self-Fitting Air-Conduction Hearing Aid, Over The Counter	Ear, Nose, Throat	Class 2	874.3325	2023-03-14

Official Correspondent

Stella Chiang

US Agent Details

Alan Chiu Email: alan-i_chiu@pegatroncorp.com Phone: (408) 9667041

Related Public Records

Same Entity

Pegatron Corporation

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 3006011998. Last updated year: 2026. Please use registration number 3006011998 when referencing this establishment in official correspondence.