ANTERION

Basic Information

• Brand Name: ANTERION
• Primary DI: 04059237000952
• Version / Model: Software V.1.5 US
• Company Name: Heidelberg Engineering GmbH
• Labeler DUNS: 329833875
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-05
• Public Version: 1
• Public Version Date: 2025-02-13
• Public Version Status: New
• Public Device Record Key: e2f58cbc-9a2f-4d36-94a0-b04ac9bf17c6

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OBO	Tomography, Optical Coherence	Ophthalmic	886.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45724	Eye anterior segment analyser software	An application software program designed for the collection, processing, and display of data resulting from the measurement/evaluation of various properties of the anterior segment of the eye (i.e., cornea, iris, pupil, anterior chamber and lens) performed with an eye anterior segment analyser. It may be installed in the integrated analyser computer and/or an off-the-shelf computer (e.g., desktop, laptop).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04059237000952	GS1

Premarket Submissions

Submission Number	Supplement Number
K240924	000