FDA Device Entity Profile: Boule Diagnostics AB

Known Identifiers & Locations

FEI Numbers 3002684533, 3004008703

Owner Operator Numbers 9034165

Locations Covered PLANTATION, FL, US; Spanga Stockholm, SE

Registered Establishments (2)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
1064130	CLINICAL DIAGNOSTIC SOLUTIONS, INC.	PLANTATION, FL, US	Repack or Relabel Medical Device,Manufacture Medical Device	View Details
3004008703	BOULE MEDICAL AB	Spanga Stockholm, SE	Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (0)

No recall records found for this entity.

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