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KULZER GMBH — FDA Facility Profile

FEI 3002807166

KULZER GMBH is an FDA-registered facility (FEI 3002807166) located in WEHRHEIM Hesse, DE. RegDataLab tracks 1 FDA inspection at this facility.

Facility Details

Location
WEHRHEIM Hesse (DE)
Registration Expires
N/A
Operations
Source
device

Recent inspections

  • 909484 (NAI Thu Dec 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • 8E4-0252114-1/11/1 (Fri Apr 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 823-0208149-0/121/1 (Mon Aug 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 823-0203250-1/61/2 (Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 823-0203250-1/61/3 (Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 823-0203250-1/61/1 (Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 823-0203250-1/61/4 (Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 98F-0028490-9/11/2 (Tue Feb 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 322-1752448-1/31/1 (Mon Jan 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-9377741-0/1/1 (Thu May 28 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources