FDA Import Refusal AEK-9286826-2/10002/1 — FOTONA D.O.O.

FOTONA D.O.O. — FEI 1000597018

The FDA refused shipment AEK-9286826-2/10002/1 from FOTONA D.O.O. (Slovenia) on Jan 30, 2026. The refused product falls under Devices — POWERED LASER SURGICAL INSTRUMENTS. Cited charge: 47 This firm has 5 or more other import refusals on record.

Refusal Details

Date
Jan 30, 2026
Country
Slovenia
Product Category
Devices
Product Code
79GEX POWERED LASER SURGICAL INSTRUMENTS
Charges
47

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.