Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006948155

FEI Number

3009865005

Entity Name

PT Giken Precision Indonesia

City/State/Country

Batam Riau, ID

Establishment Address

JL. Yos Sudarso Citra Buana Industrial Park II Lot 2 Batu Ampar Batam, Batam Riau 29432, ID

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Giken Sakata (S) Ltd (Owner Number: 10087342)

Owner / Operator Contact Address

Blk 4012 Ang Mo Kio Ave 10, #05-01 Techplace 1, Singapore, SG-01 569628, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TelePatch Cardiac Monitor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2023-02-15
MLO	Electrocardiograph, Ambulatory, With Analysis Algorithm	Cardiovascular	Class 2	870.2800	2023-02-15

Official Correspondent

James Poo

US Agent Details

Bayan Saleh Business: ReactDx Email: bayan.saleh@reactdx.com Phone: (877) 9965553

Related Public Records

Same Entity

Giken Sakata (S) Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K131913	Philips Medizin Systeme Boeblingen GmbH	INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC	2013-11-26

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3012302888	QUIPMENT INC.	Kennesaw, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006948155. Last updated year: 2026. Please use registration number 3006948155 when referencing this establishment in official correspondence.