Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013294311

FEI Number

3013294311

Entity Name

INTEGRATED MICRO-ELECTRONICS INC. (IMI)

City/State/Country

Binan Laguna, PH

Establishment Address

North Science Avenue, Laguna Technopark-Special Economic Zone (LT-SEZ), Binan Laguna 4024, PH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

INTEGRATED MICRO-ELECTRONICS INC. (IMI) (Owner Number: 10058003)

Owner / Operator Contact Address

NORTH SCIENCE AVENUE, LAGUNA TECHNOPARK-SPECIAL ECONOMIC ZONE (LT-SEZ), Binan, PH-LAG 4024, PH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Signia Intuis Signia IX Signia Insio Rexton Emerald Signia Pure Signia AX Insio Charge&Go Signia Styletto Intuis 3 Intuis 4 Signia Motion CROS AX Pure Charge&Go Signia Silk Insio IX Signia CROS Styletto AX Signia Ace Motion Charge&Go hear.com Rexton BiCore Signia Pure Charge&Go Signia AX Signia IX Widex Moment Sheer ALLURE Widex Moment Widex SmartRIC Horizon Mini IX Widex CROS

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	2018-06-24
QDD	Self-Fitting Air-Conduction Hearing Aid, Prescription	Ear, Nose, Throat	Class 2	874.3325	2022-08-24
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2018-06-24

Official Correspondent

Isabel Restivo

US Agent Details

Isabel Restivo Business: WS Audiology USA, Inc. Email: isabel.restivo@wsa.com Phone: (551) 5799581

Related Public Records

Same Entity

INTEGRATED MICRO-ELECTRONICS INC. (IMI)

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 3013294311. Last updated year: 2026. Please use registration number 3013294311 when referencing this establishment in official correspondence.