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Data / Medical devices / United States / Aldi, Inc.

Aldi, Inc.: FDA-registered device maker in Batavia, IL, United States, 3 510(k) clearances

Aldi, Inc. is registered with the FDA (registration 1419898) in Batavia, IL, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 22, 2017. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
1419898
Address
1200 North Kirk RD., Batavia, IL, United States, 60510
Owner or operator
Aldi USA (9005174)
Roles
Repackager or relabeler
First device listed
November 12, 2020
Registered through
2027
Brand names listed
Visage

Devices it lists

DeviceProduct codeClassRoleSource
Continuous Measurement ThermometerFLL2Repackager or relabeleraccessdata.fda.gov
Frame, SpectacleHQZ1Repackager or relabeleraccessdata.fda.gov
OximeterDQA2Repackager or relabeleraccessdata.fda.gov
Spectacle, MagnifyingHOI1Repackager or relabeleraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 22, 2017K170666The Wrist-Type Fully Automatic Digital Blood Pressure MonitorsDXNSubstantially EquivalentJoytech Healthcare Co. , Ltd.accessdata.fda.gov
November 17, 2016K161735Non-contact Forehead ThermometerFLLSubstantially EquivalentShenzhen Dongdixin Technology Co., Ltd.accessdata.fda.gov
November 10, 2008K082641FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DLDQASubstantially EquivalentContec Medical System Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated November 22, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.