FDA Establishment Registration & Device Listing
Registered operations. Product-specific records.
OneTouch Medical operates within the applicable FDA establishment-registration and device-listing framework for its regulated medical-device activities and products. Our manufacturing operations include an FDA-registered establishment, with applicable device listings maintained as required for regulated activities.
View FDA Registration & Listing →Regulatory notice. FDA establishment registration, assignment of a registration number, or device listing does not by itself denote FDA approval, clearance, endorsement, or authorization of an establishment or product. Product-specific claims should be based on the applicable FDA record, labeling and regulatory status.