Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029924313

FEI Number

3029924313

Entity Name

PT KEPLER SIGNALTEK INDONESIA

City/State/Country

Batam Kepulauan Riau, ID

Establishment Address

Kawasan Gapura Nomor 1-3 dan 3A, Desa/Kelurahan, Muka Kuning, Kec. Sei Beduk,Kota, Batam Kepulauan Riau 29433, ID

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PT Kepler SignalTek Indonesia (Owner Number: 10088705)

Owner / Operator Contact Address

Kawasan Gapura Nomor 1-3 dan 3A, Desa/Kelurahan, Muka Kuning, Kec. Sei Beduk, Kota, Batam, ID-KR 29433, ID

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
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2023-10-09

Official Correspondent

Desmond Low

US Agent Details

Scott Hayden Business: Kepler SignalTek LTD Email: scott.hayden@keplersignaltek.com Phone: (802) 3738695

Related Public Records

Same Entity

PT Kepler SignalTek Indonesia

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 3029924313. Last updated year: 2026. Please use registration number 3029924313 when referencing this establishment in official correspondence.