Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008305513

FEI Number

3008305513

Entity Name

PT OSI Electronics

City/State/Country

Batam Centre Riau, ID

Establishment Address

Cammo Industrial Park Block F No. 3A, Batam Centre Riau 29432, ID

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

OSI Electronics Pte Ltd (Owner Number: 10042987)

Owner / Operator Contact Address

Pines Industrial Building 240 MacPherson Road #07-05, Singapore, SG-01 348574, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MX3 Vie Scope

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJM	Osmometer For Clinical Use	Clinical Chemistry	Class 1	862.2730	2025-04-17
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2017-12-13

Official Correspondent

Emma Rahmawati

US Agent Details

Kevin Jardim Email: KJardim@osioptoelectronics.com Phone: (310) 3492624

Related Public Records

Same Entity

OSI Electronics Pte Ltd

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

Similar Registrations

Registration Number	Establishment Name	Location
1717966	ELITechGroup Inc	LOGAN, UT, US
3009155756	Guangzhou Four E's Scientific Co., Ltd.	GUANGZHOU Guangdong, CN
3043088937	SCITEK GLOBAL CO.,LTD	Jinan Shandong, CN
1217058	Advanced Instruments, LLC	NORWOOD, MA, US
1250003	PRECISION SYSTEMS, INC.	NATICK, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008305513. Last updated year: 2026. Please use registration number 3008305513 when referencing this establishment in official correspondence.