Sanmina-SCI Systems Singapore Pte. Ltd.

FDA Device Registration & Listing · SINGAPORE North East, SG · Registration 3006606827

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006606827
FEI Number
3006606827
Entity Name
Sanmina-SCI Systems Singapore Pte. Ltd.
City/State/Country
SINGAPORE North East, SG
Establishment Address
2 Chai Chee Drive, SINGAPORE North East 469044, SG
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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

FloTrak Elite module Alinity hq (09P68-02) Alinity hs (09P69-02) intelliVue Smart-hopping APC , IntelliVue Smart-hopping Sync NightOwl Mini Expression MR400 MRI Patient Monitoring System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2020-04-03
BZK Spirometer, Monitoring (W/Wo Alarm) Anesthesiology Class 2 868.1850 2020-04-03
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2025-02-27
KPA Slide Stainer, Automated Pathology Class 1 864.3800 2025-02-27
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2018-04-17
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2023-05-17
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2019-12-10

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
K142467 Abeon Medical Corporation IntelAir Nasal Airway Support System 2014-11-24
K861213 Datex Division Instrumentarium Corp. PB 254 IR - SPECTROMETER 1986-04-04
K172904 Philips Medizin Systeme Boeblingen GmbH IntelliVue Capnography Extension, IntelliVue Microstream Extension 2017-12-26
K910283 Danam Electronics DANAM DATACELL-18 1991-04-12
K102064 Becton, Dickinson & CO BD FACS SAMPLE PREP ASSISTANT III (SPA III) 2011-03-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0021-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006606827. Last updated year: 2026. Please use registration number 3006606827 when referencing this establishment in official correspondence.
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