# Sysmex Europe SE

FEI: 3005626422
Status: Active
Establishment types: Export Device to the United States But Perform No Other Operation on Device
Owner/operator: SYSMEX CORPORATION (#9014170)

Address: Mainstrasse 7, Neumunster Schleswig-Holstein, D-24539, DE

Mandatory US Agent: SYSMEX AMERICA, INC

## Products

Total registered: 1
Top product codes: MVU
Regulation §: 864.4020

Proprietary names: CyFlow IFN-gamma FITC, CyFlow CD45 Pacific Blue, CyFlow CD13 APC, CyFlow CD235a PE, CyFlow Kappa-LC Pacific Blue, CyFlow CD56 FITC, CyFlow CD56 PE, CyFlow CD13 PE, CyFlow Kappa-LC APC, CyFlow CD45 FITC

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223005626422%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3005626422