Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008202779

FEI Number

3008202779

Entity Name

CELESTICA ELECTRONICS (S) PTE LTD.

City/State/Country

Singapore Central Singapore, SG

Establishment Address

6 Serangoon North Avenue 5, #05-03/04, #05-06/07/08, Singapore Central Singapore 554910, SG

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Celestica Electronics (S) Pte Ltd. (Owner Number: 10037016)

Owner / Operator Contact Address

6 Serangoon North Avenue 5 #06-11, Singapore, SG-01 554910, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ReliaCatch Specimen Retrieval Bag 10mm ReliaCatch Specimen Retrieval Bag 12mm Kit, Box of 10 PMSENS71-P INVOS Pediatric rSO2 Sensor Kit, Box of 20 PMSENS71-P INVOS Pediatric rSO2 Sensor Kit, Box of 5 PMSENS71-P INVOS Pediatric rSO2 Sensor Kit, Box of 20 PMSENS71-A Sensors Adult INVOS Kit, Box of 5 PMSENS71-A Sensors Adult INVOS Kit, Box of 10 PMSENS71-A Sensors Adult INVOS 186-0160 BIS Extend Sensor 186-0150-PH BIS Quatro Sensor Starter Kit, Philips 186-0200 BIS Pediatric-XP Sensor 186-0212-PH Philips Bilateral Sensor Kit 186-0212 BIS Bilateral Sensor 186-0150 Quatro Sensor Starter Kit 186-0106 BIS Quatro Sensor 186-0106-PH Case, Sensor, Quatro, Philips 186-0137 BIS Sensor Simulator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-01-12
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2022-02-04
QEM	Cerebral Oximeter	Cardiovascular	Class 2	870.2700	2022-02-04
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2019-01-21
QEM	Cerebral Oximeter	Cardiovascular	Class 2	870.2700	2019-01-21
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2016-08-16
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2015-04-14
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2015-04-14
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2015-04-14

Official Correspondent

Chee Keong Yee

US Agent Details

Payal Copling Email: payal.copling@celestica.com Phone: (469) 3953251

Related Public Records

Same Entity

Celestica Electronics (S) Pte 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
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

Similar Registrations

Registration Number	Establishment Name	Location
3016804805	CLEARCAM	Austin, TX, US
3011936016	Sony Olympus Medical Solutions Inc.	Hachioji-shi Tokyo, JP
3015335150	VERNACARE LTD.	Chorley Lancashire, GB
1221072	VASCULAR TECHNOLOGY INCORPORATED	NASHUA, NH, US
3021744308	Lazurite Inc.	Cleveland, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008202779. Last updated year: 2026. Please use registration number 3008202779 when referencing this establishment in official correspondence.