Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000486410

FEI Number

1000486410

Entity Name

KNOWLES ELECTRONICS (MALAYSIA) SDN. BHD.

City/State/Country

BAYAN LEPAS Pulau Pinang, MY

Establishment Address

Plot 104, Lebuhraya Kg Jawa, Bayan Lepas Industrial Park, BAYAN LEPAS Pulau Pinang 11900, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Knowles Electronics (Malaysia) Sdn. Bhd. (Owner Number: 10094027)

Owner / Operator Contact Address

Plot 104, Lebuhraya Kg Jawa, Bayan Lepas Industrial Park, BAYAN LEPAS, MY-07 11900, MY

Initial Importer Flag

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
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2026-02-27

Official Correspondent

Yoke San Chiang

US Agent Details

Sandeep Krishnakumar Business: Knowles Electronics Itasca Email: Sandeep.Krishnakumar@knowles.com Phone: (773) 6060576

Related Public Records

Same Entity

Knowles Electronics (Malaysia) Sdn. Bhd.

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 1000486410. Last updated year: 2026. Please use registration number 1000486410 when referencing this establishment in official correspondence.