Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1037998

FEI Number

1037998

Entity Name

Sanmina, Huntsville, AL

City/State/Country

HUNTSVILLE, AL, US

Establishment Address

13000 Memorial Pkwy Sw, HUNTSVILLE, AL 35803, US

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

ACCU-CHEK GUIDE LINK mmol/L 114 ACCU-CHEK GUIDE LINK MG/DL 115 (JAPAN) ACCU-CHEK GUIDE LINK MG/DL 113 ACCU-CHEK INFORM II MEASUREMENT ENGINE Artisse Detachment Device US Guide Link 118 meter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2020-05-20
OPR	Intrasaccular Flow Disruption Device	Unknown	Class 3	N/A	2023-12-11
OZP	Automated Insulin Dosing Device System, Single Hormonal Control	Unknown	Class 3	N/A	2020-09-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
K150396	Apex BioTechnology Corp.	Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips	2015-10-14
K150833	Andon Health Co, Ltd.	iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System	2015-12-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06	Abbott Laboratories Medisense Products	2	Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06	Abbott Laboratories Medisense Products	2	Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0003-2025	Medtronic MiniMed, Inc.	3	MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762; MiniMed 770G, REF: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 780G, REF: MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1037998. Last updated year: 2026. Please use registration number 1037998 when referencing this establishment in official correspondence.