# BOULE MEDICAL AB

FEI: 3004008703
Status: Active
Establishment types: Export Device to the United States But Perform No Other Operation on Device; Manufacture Medical Device
Owner/operator: Boule Diagnostics AB (#9034165)

Address: Fagerstagatan 7, Spanga Stockholm, 163 53, SE

Mandatory US Agent: Clinical Diagnostics Solutions

## Products

Total registered: 1
Top product codes: GKZ
Regulation §: 864.5220

Proprietary names: Medonic M-series

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223004008703%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3004008703