K-number	K252140
Device name	Heylo System
Applicant	Coloplast Corp.
Product code	EXB
Device class	Class I
Decision date	Oct 6, 2025
Decision	Substantially Equivalent
Regulation	876.5900

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Heylo System

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Heylo System