Home / Import refusals / SCS-9193527-4/41/1

FDA Import Refusal SCS-9193527-4/41/1 — Spacelabs Healthcare, Ltd.

Spacelabs Healthcare, Ltd. — FEI 3002807992

The FDA refused shipment SCS-9193527-4/41/1 from Spacelabs Healthcare, Ltd. (United Kingdom) on March 7, 2025. The refused product falls under Devices — SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE. Cited charges: 3280,341 This firm has 5 or more other import refusals on record.

Refusal Details

Date
March 7, 2025
Country
United Kingdom
Product Category
Devices
Product Code
74DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Charges
3280,341

Recent inspections

  • 1035732 (NAI Wed Nov 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • SCS-9180651-7/41/1 (Thu Mar 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-9180651-7/51/1 (Thu Mar 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-9180651-7/61/1 (Thu Mar 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-9193527-4/51/1 (Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-9193527-4/61/1 (Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources