FDA Import Refusal 799-3211328-1/10002/1 — WELLCOMET GMBH

WELLCOMET GMBH — FEI 3021611070

The FDA refused shipment 799-3211328-1/10002/1 from WELLCOMET GMBH (Germany) on Mar 19, 2026. The refused product falls under Devices — FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION. Cited charges: 118,3280,341,3904,3905,476 This firm has 2 other import refusals on record.

Refusal Details

Date
Mar 19, 2026
Country
Germany
Product Category
Devices
Product Code
79OHV FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION
Charges
118,3280,341,3904,3905,476

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