Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007923088

FEI Number

3007923088

Entity Name

Sanmina-SCI Systems (Malaysia) Sdn Bhd

City/State/Country

Perai Pulau Pinang, MY

Establishment Address

202 Lorong Perusahaan Maju 9, Bukit Tengah Industrial Park, Perai Pulau Pinang 13600, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Sanmina Corporation (Owner Number: 2129538)

Owner / Operator Contact Address

13000 S. Memorial Pkwy, --, Huntsville, AL 35803, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cell Saver Elite/Elite+ PCS®2 NexSys PCS with Persona PLUS Technology IntelliBridge EC 40/80 TxLink 2 Connection Module ASP ACCESS Data Station ACP¿ 215 NexSys PCS NexSys, PCS, Express Plus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2023-12-12
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-01-06
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2026-03-05
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2017-08-10
KSW	System, Processing For Frozen Blood	Hematology	Class 2	864.9145	2014-01-06
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2017-08-14
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2024-06-13

Official Correspondent

No official correspondent registered.

US Agent Details

Jeffrey Stahl Business: Sanmina Email: jeffrey.stahl@sanmina.com Phone: (256) 8824125

Related Public Records

Same Entity

Sanmina Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004139819	Sanmina Ireland UC	FERMOY, CORK Munster, IE
3004201275	SANMINA-SCI AB	SJALEVAD Vasternorrland, SE
3009609218	Sanmina Corporation	Carrollton, TX, US
3007867838	Sanmina	SAN JOSE, CA, US
3004016520	SANMINA- SCI ISRAEL MEDICAL SYSTEMS LTD.	Maalot-Tarshiha Northern, IL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881350	Stryker Corp.	CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM	1988-09-30

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9680841	SORIN GROUP ITALIA S.R.L	MIRANDOLA Modena, IT
3006654680	Miller Technical Services	Plymouth, MI, US
1424263	Isomedix Operations, Inc.	Libertyville, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007923088. Last updated year: 2026. Please use registration number 3007923088 when referencing this establishment in official correspondence.