Breas Medical Ab

FDA Filings

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

Breas Medical Ab holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number9617566
FEI Number3003244771
NameBREAS MEDICAL AB
Owner & OperatorBreas Medical AB
Contact AddressForetagsvagen 1,
Molnlycke SE-O Vastra Gotalands lan [SE-14] SE-43533 SE
Official Correspondent
  • Ari Sobel
  • 46-31-868819-x
US Agent
Importing Logistics Registration
ImporterBreas Medical AB
AddressF?retagsv?gen 1
M?lnlycke, 43533 SWEDEN
Email Addressajrulla.zuta@ge.com
Phone46 31 868819
Importer TypeManufacturer
SubdivisionSE-O
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressFORETAGSVAGEN 1
MOLNLYCKE Vastra Gotalands lan [SE-14], 435 33 SE
Establishment Type
  • Remanufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device



FDA Filings

Device
Company
DeviceDate
Breas Medical AB
Vivo 45 LS2021-01-27
Breas Medical AB
Vivo 65 2245162018-07-06
Breas Medical AB
Vivo 50 2151162018-07-06
Breas Medical AB
Vivo 50 2150162018-07-06
Breas Medical AB
Vivo 50 2150002018-07-06
Breas Medical AB
Breas iSleep 20i system 2070002018-07-06
Breas Medical AB
Breas iSleep 20+ system 2060002018-07-06
Breas Medical AB
Breas Vivo 30 System 2020002018-07-06
Breas Medical AB
Breas Vivo 40 System 2010002018-07-06
Breas Medical AB
HA01 0035302018-03-29
Breas Medical AB
Breas iSleep 20 System 2050002018-03-29
BREAS MEDICAL AB
Vivo 652016-11-11
BREAS MEDICAL AB
Vivo 652016-11-11
BREAS MEDICAL AB
Vivo 652016-11-11
BREAS MEDICAL AB
Vivo 652016-11-11
BREAS MEDICAL AB
Vivo 602016-11-09
BREAS MEDICAL AB
Oxygen Sensors2014-12-30
BREAS MEDICAL AB
T-Piece US2014-12-19
BREAS MEDICAL AB
Vivo 502014-02-27
BREAS MEDICAL AB
Vivo 502014-02-27
BREAS MEDICAL AB
Vivo 502014-02-27
BREAS MEDICAL AB
Vivo 502014-02-27
BREAS MEDICAL AB
BREAS VIVO 402014-02-27
BREAS MEDICAL AB
BREAS VIVO 40 SYSTEM2014-02-27
BREAS MEDICAL AB
Breas iSleep 20i System2014-02-27
BREAS MEDICAL AB
Breas iSleep 20+ System2014-02-27
BREAS MEDICAL AB
Model HA01; Breas2014-02-27
BREAS MEDICAL AB
Breas iSleep 20 System2014-02-27
BREAS MEDICAL AB
Breas iSleep 10 System2014-02-27
BREAS MEDICAL AB
BREAS VIVO 30 SYSTEM2014-02-27
BREAS MEDICAL AB
Breas Vivo 402014-02-27
BREAS MEDICAL AB
IMASK MODEL 100, IMASK MODEL 200, IMASK MODEL 3002014-02-27
BREAS MEDICAL AB
IMASK TM2014-02-27
BREAS MEDICAL AB
BREAS PV 10i CPAP System, Model PV10i2014-02-27
BREAS MEDICAL AB
BREAS HA50 Humidifier, Model HA 502014-02-27
BREAS MEDICAL AB
BREAS PV 100 CPAP System2014-02-27
BREAS MEDICAL AB
Single Patient Breathing Hose, Breathing Therapy Equipment Patient Circuit, Single Limb with Leakage Port, Disposable, B2014-02-27
BREAS MEDICAL AB
BREAS VIVO 40 SYSTEM2009-05-14
BREAS MEDICAL AB
BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 402008-02-15
BREAS MEDICAL AB
BREAS ISLEEP 20I2007-01-22
BREAS MEDICAL AB
ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.2006-08-18
BREAS MEDICAL AB
BREAS ISLEEP 20+2006-06-23
BREAS MEDICAL AB
BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 302006-05-26
BREAS MEDICAL AB
BREAS, MODEL HA012006-05-25
BREAS MEDICAL AB
BREAS VIVO 40 SYSTEM2006-03-16

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
202008286678Bremerhaven,Federal Republic of Germany -> Boston, MassachusettsTROLLEY200 CTN
2020031659651Tampico,Mexico -> Houston, TexasPANASONIC MEXICO1 PKG
2019102436569Gothenburg,Sweden -> Boston, MassachusettsMEDICAL EQUIPMENT1 PKG
201910245327Gothenburg,Sweden -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENT1 PKG
2019100833768Gothenburg,Sweden -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENT1 PKG
2019100537925Gothenburg,Sweden -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENT1 PKG
2019100431585Gothenburg,Sweden -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENT1 PKG
2019092816898Gothenburg,Sweden -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENT1 PKG

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