Boule Medical Ab

FDA Filings

This page includes the latest FDA filings for Boule Medical Ab. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3004008703
FEI Number3004008703
NameBOULE MEDICAL AB
Owner & OperatorBoule Diagnostics AB
Contact AddressDomnarvsgatan 4
Spanga SE-NOTA SE-163 53 SE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressDomnarvsgatan 4
Spanga Stockholms lan [SE-01], SE-163 53 SE
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
Boule Medical AB
 Swelab Lumi-L2 Lyse 15045162024-10-14
Boule Medical AB
 Swelab Lumi-L1 Lyse 15045152024-10-14
Boule Medical AB
 Swelab Lumi-D Diluent 15045142024-10-14
Boule Medical AB
 Medonic M51-L2 Lyse 15045122024-10-14
Boule Medical AB
 Medonic M51-L1 Lyse 15045112024-10-14
Boule Medical AB
 Medonic M51-D Diluent 15045102024-10-14
Boule Medical AB
 Boule EasyCleaner 15045132024-10-14
Boule Medical AB
 Micro pipette, plastic EDTA 10700392024-10-14
Boule Medical AB
 Medonic M-series 14000752019-12-23
Boule Medical AB
 Medonic M-series 14000742019-12-23
Boule Medical AB
 Medonic M-series 140000732019-12-23
Boule Medical AB
 Medonic M-series 14001062019-12-23
BOULE MEDICAL AB [Boule Diagnostics AB]
Medonic M-series2009-07-08
BOULE MEDICAL AB
MEDONIC M SERIES2009-02-03
BOULE MEDICAL AB [Boule Diagnostics AB]
Boule, MPA Micro Pipettes Plastic2008-10-23

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020081920969Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaMEDICAL EQUIPMENT1 PCS
2020080658404Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaMEDICAL EQUIPMENT1 PCS
2020080433023Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaMEDICAL EQUIPMENT1 PCS
2020080167540Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaMEDICAL EQUIPMENT1 PCS
2020073065309Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaMEDICAL EQUIPMENT1 PCS
2020072969596Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaMEDICAL EQUIPMENT1 PCS
2020052314878Anvers,Belgium -> Charleston, South CarolinaBOTTLE, CLEANING KIT4 PKG
2019112346155Stadersand,Federal Republic of Germany -> Charleston, South CarolinaCLEANING KIT3 PKG
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