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FDA Import Refusal 1FX-2965786-3/10002/1 — MYSTIM GMBH

MYSTIM GMBH — FEI 3013774724

The FDA refused shipment 1FX-2965786-3/10002/1 from MYSTIM GMBH (Germany) on June 25, 2026. The refused product falls under Devices — STIMULATOR, PERIPHERAL NERVE, NON-IMPLANTED, FOR PELVIC FLOOR DYSFUNCTION. Cited charges: 118,3280 This firm has 5 or more other import refusals on record.

Refusal Details

Date
June 25, 2026
Country
Germany
Product Category
Devices
Product Code
78NAM STIMULATOR, PERIPHERAL NERVE, NON-IMPLANTED, FOR PELVIC FLOOR DYSFUNCTION
Charges
118,3280

Other import refusals

  • 1FX-2965786-3/30002/1 (Thu Jun 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-2430983-4/41/1 (Tue Jan 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-2430983-4/11/1 (Tue Jan 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-4899685-4/11/2 (Wed Oct 20 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-4899685-4/11/1 (Wed Oct 20 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources