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:

• BREAS MEDICAL AB

FDA Registration(s)

• Registration Number: 9617566
• FEI Number: 3003244771
• Name: BREAS MEDICAL AB
• Owner & Operator: Breas Medical AB
• Contact Address: Foretagsvagen 1, ; Molnlycke SE-O Vastra Gotalands lan [SE-14] SE-43533 SE
• Official Correspondent:
  • Ari Sobel
  • 46-31-868819-x
• US Agent:
  • Ian Liu
  • Breas Medical AB
  • 857 4170869
  • ian.liu@breas.com
• Importing Logistics Registration:
  • Importer: Breas Medical AB
  • Address: F?retagsv?gen 1 ; M?lnlycke, 43533 SWEDEN
  • Email Address: ajrulla.zuta@ge.com
  • Phone: 46 31 868819
  • Importer Type: Manufacturer
  • Subdivision: SE-O
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: FORETAGSVAGEN 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	Device	Date
GUDID 07321820084364 Breas Medical AB	Vivo 45 LS 008436	2022-06-27
GUDID 07321820083923 Breas Medical AB	Vivo 45 LS 008392	2022-06-27
GUDID 07321820079179 Breas Medical AB	Ventilator Trolley 007917	2022-06-27
GUDID 07321820079162 Breas Medical AB	Ventilator Trolley 007916	2022-06-27
GUDID 07321820078592 Breas Medical AB	Ventilator Trolley 007859	2022-06-27
GUDID 07321820078585 Breas Medical AB	Ventilator Trolley 007858	2022-06-27
GUDID 07321820077335 Breas Medical AB	Vivo 45 LS 007733	2022-06-27
GUDID 07321820077328 Breas Medical AB	Vivo 45 LS 007732	2022-06-27
GUDID 07321820076543 Breas Medical AB	Vivo 45 LS 007654	2022-06-27
GUDID 07321820075553 Breas Medical AB	Vivo 45 LS 007555	2022-06-27
GUDID 07321820073849 Breas Medical AB	Ventilator Trolley 007384	2022-06-27
GUDID 07321820072194 Breas Medical AB	Vivo 50 007219	2022-06-27
GUDID 07321820070671 Breas Medical AB	Vivo 45 LS 007067	2022-06-27
GUDID 07321820070640 Breas Medical AB	Vivo 45 LS 007064	2022-06-27
GUDID 07321820067619 Breas Medical AB	Ventilator Trolley 006761	2022-06-27
GUDID 07321820067114 Breas Medical AB	Vivo 45 LS 006711	2022-06-27
GUDID 07321820067107 Breas Medical AB	Vivo 45 LS 006710	2022-06-27
GUDID 07321820067091 Breas Medical AB	Vivo 45 LS 006709	2022-06-27
GUDID 07321820067084 Breas Medical AB	Vivo 50, Vivo 65, Vivo 45 LS 006708	2022-06-27
GUDID 07321820066490 Breas Medical AB	Vivo 45 LS 006649	2022-06-27
GUDID 07321820065561 Breas Medical AB	Vivo 45 LS 007105	2022-06-27
GUDID 07321820064571 Breas Medical AB	Vivo 45 LS 007103	2022-06-27
GUDID 07321820064564 Breas Medical AB	Vivo 45 LS 007104	2022-06-27
GUDID 07321820063963 Breas Medical AB	Vivo 45 LS 006396	2022-06-27
GUDID 07321820063697 Breas Medical AB	Vivo 45 LS, Vivo 65 006369	2022-06-27
GUDID 07321820063659 Breas Medical AB	Vivo 45 LS, Vivo 65 006365	2022-06-27
GUDID 07321820063642 Breas Medical AB	Vivo 45 LS, Vivo 65 006364	2022-06-27
GUDID 07321820063635 Breas Medical AB	Vivo 45 LS, Vivo 65 006363	2022-06-27
GUDID 07321820063628 Breas Medical AB	Vivo 45 LS, Vivo 65 006362	2022-06-27
GUDID 07321820063611 Breas Medical AB	Vivo 45 LS, Vivo 65 006361	2022-06-27
GUDID 07321820063604 Breas Medical AB	Vivo 45 LS, Vivo 65 006360	2022-06-27
GUDID 07321820063598 Breas Medical AB	Vivo 45 LS, Vivo 65 006359	2022-06-27
GUDID 07321820063499 Breas Medical AB	Vivo 45 LS, Vivo 65 006349	2022-06-27
GUDID 07321820063482 Breas Medical AB	Vivo 45 LS, Vivo 65 006348	2022-06-27
GUDID 07321820063444 Breas Medical AB	Vivo 50, VIvo 65 006344	2022-06-27
GUDID 07321820063420 Breas Medical AB	Vivo 65 006342	2022-06-27
GUDID 07321820062652 Breas Medical AB	Vivo 45 LS 006265	2022-06-27
GUDID 07321820062362 Breas Medical AB	Vivo Series 006093	2022-06-27
GUDID 07321820061808 Breas Medical AB	Vivo 45 LS 006180	2022-06-27
GUDID 07321820061792 Breas Medical AB	Vivo 45 LS 006179	2022-06-27
GUDID 07321820061723 Breas Medical AB	Vivo 45 LS 006172	2022-06-27
GUDID 07321820061259 Breas Medical AB	Vivo 65 006435	2022-06-27
GUDID 07321820060955 Breas Medical AB	Ventilator Trolley 006095	2022-06-27
GUDID 07321820060672 Breas Medical AB	Vivo 45 LS 006067	2022-06-27
GUDID 07321820060146 Breas Medical AB	Vivo 45 LS 006014	2022-06-27
GUDID 07321820059287 Breas Medical AB	Vivo 50 005928	2022-06-27
GUDID 07321820057917 Breas Medical AB	Vivo 65 005525	2022-06-27
GUDID 07321820057900 Breas Medical AB	Vivo 65 005523	2022-06-27
GUDID 07321820055210 Breas Medical AB	Vivo 65 005521	2022-06-27
GUDID 07321820054329 Breas Medical AB	Vivo 65 005432	2022-06-27
GUDID 07321820054299 Breas Medical AB	Vivo 50 005429	2022-06-27
GUDID 07321820054282 Breas Medical AB	Vivo 50 005428	2022-06-27
GUDID 07321820052233 Breas Medical AB	Vivo 50 005223	2022-06-27
GUDID 07321820051892 Breas Medical AB	Vivo 50, VIvo 65 005189	2022-06-27
GUDID 07321820051205 Breas Medical AB	Vivo Series 005120	2022-06-27
GUDID 07321820051007 Breas Medical AB	Vivo 50, VIvo 65 005100	2022-06-27
GUDID 07321820050949 Breas Medical AB	Vivo 50 005094	2022-06-27
GUDID 07321820050666 Breas Medical AB	Vivo 50, Vivo 65 005066	2022-06-27
GUDID 07321820050369 Breas Medical AB	Vivo 50 005036	2022-06-27
GUDID 07321820050321 Breas Medical AB	Vivo 50, Vivo 65, Vivo 45 LS 005032	2022-06-27
GUDID 07321820049394 Breas Medical AB	Vivo 50, VIvo 65 004939	2022-06-27
GUDID 07321820049011 Breas Medical AB	Vivo 50, Vivo 65, Vivo 45 LS 004901	2022-06-27
GUDID 07321820048991 Breas Medical AB	Vivo 50, Vivo 65 004886	2022-06-27
GUDID 07321820048984 Breas Medical AB	Vivo 50 004898	2022-06-27
GUDID 07321820048977 Breas Medical AB	Vivo 50 004897	2022-06-27
GUDID 07321820048960 Breas Medical AB	Vivo 50 004896	2022-06-27
GUDID 07321820048946 Breas Medical AB	Vivo 50 004894	2022-06-27
GUDID 07321820048939 Breas Medical AB	Vivo 50 004893	2022-06-27
GUDID 07321820048922 Breas Medical AB	Vivo 50 004892	2022-06-27
GUDID 07321820048915 Breas Medical AB	Vivo 50 004891	2022-06-27
GUDID 07321820048861 Breas Medical AB	Vivo 50, Vivo 65 004886	2022-06-27
GUDID 07321820046683 Breas Medical AB	Vivo 50, VIvo 65 004910	2022-06-27
GUDID 07321820046676 Breas Medical AB	Vivo 50, VIvo 65 004909	2022-06-27
GUDID 07321820045594 Breas Medical AB	Vivo 50, VIvo 65 004559	2022-06-27
GUDID 07321820044269 Breas Medical AB	Vivo Series 004426	2022-06-27
GUDID 07321820035229 Breas Medical AB	Vivo 45 LS 003522	2022-06-27
GUDID 07321820021857 Breas Medical AB	Vivo 50, Vivo 65, Vivo 45 LS 002185	2022-06-27
GUDID 07321822300004 Breas Medical AB	Vivo 45 LS 230000	2021-04-26
PMN K193586 Breas Medical AB	Vivo 45 LS	2021-01-27
GUDID 07321822245169 Breas Medical AB	Vivo 65 224516	2018-07-06
GUDID 07321822151163 Breas Medical AB	Vivo 50 215116	2018-07-06
GUDID 07321822150166 Breas Medical AB	Vivo 50 215016	2018-07-06
GUDID 07321822150005 Breas Medical AB	Vivo 50 215000	2018-07-06
GUDID 07321822070167 Breas Medical AB	Breas iSleep 20i system 207000	2018-07-06
GUDID 07321822060168 Breas Medical AB	Breas iSleep 20+ system 206000	2018-07-06
GUDID 07321822020162 Breas Medical AB	Breas Vivo 30 System 202000	2018-07-06
GUDID 07321822010163 Breas Medical AB	Breas Vivo 40 System 201000	2018-07-06
GUDID 07321822110160 Breas Medical AB	HA01 003530	2018-03-29
GUDID 07321822050169 Breas Medical AB	Breas iSleep 20 System 205000	2018-03-29
PMN K160481 | NOU BREAS MEDICAL AB	Vivo 65	2016-11-11
PMN K160481 | DQA BREAS MEDICAL AB	Vivo 65	2016-11-11
PMN K160481 | CCK BREAS MEDICAL AB	Vivo 65	2016-11-11
PMN K160481 | CBK BREAS MEDICAL AB	Vivo 65	2016-11-11
PMN K160481 BREAS MEDICAL AB	Vivo 60	2016-11-09
PMN K002384 | CCL BREAS MEDICAL AB	Oxygen Sensors	2014-12-30
CAI BREAS MEDICAL AB	T-Piece US	2014-12-19
PMN K123144 | NOU BREAS MEDICAL AB	Vivo 50	2014-02-27
PMN K123144 | DQA BREAS MEDICAL AB	Vivo 50	2014-02-27
PMN K123144 | CCK BREAS MEDICAL AB	Vivo 50	2014-02-27
PMN K123144 | CBK BREAS MEDICAL AB	Vivo 50	2014-02-27
PMN K090113 | MNT BREAS MEDICAL AB	BREAS VIVO 40	2014-02-27
PMN K071702 | MNT BREAS MEDICAL AB	BREAS VIVO 40 SYSTEM	2014-02-27
PMN K063476 | BZD BREAS MEDICAL AB	Breas iSleep 20i System	2014-02-27
PMN K061057 | BZD BREAS MEDICAL AB	Breas iSleep 20+ System	2014-02-27
PMN K060790 | BTT BREAS MEDICAL AB	Model HA01; Breas	2014-02-27
PMN K060657 | BZD BREAS MEDICAL AB	Breas iSleep 20 System	2014-02-27
PMN K060657 | BZD BREAS MEDICAL AB	Breas iSleep 10 System	2014-02-27
PMN K060546 | MNS BREAS MEDICAL AB	BREAS VIVO 30 SYSTEM	2014-02-27
PMN K053607 | MNT BREAS MEDICAL AB	Breas Vivo 40	2014-02-27
PMN K051559 | BZD BREAS MEDICAL AB	IMASK MODEL 100, IMASK MODEL 200, IMASK MODEL 300	2014-02-27
PMN K041309 | BZD BREAS MEDICAL AB	IMASK TM	2014-02-27
PMN K030985 | BZD BREAS MEDICAL AB	BREAS PV 10i CPAP System, Model PV10i	2014-02-27
PMN K002454 | BTT BREAS MEDICAL AB	BREAS HA50 Humidifier, Model HA 50	2014-02-27
PMN K001553 | BZD BREAS MEDICAL AB	BREAS PV 100 CPAP System	2014-02-27
BZO BREAS MEDICAL AB	Single Patient Breathing Hose, Breathing Therapy Equipment Patient Circuit, Single Limb with Leakage Port, Disposable, B	2014-02-27
PMN K090113 BREAS MEDICAL AB	BREAS VIVO 40 SYSTEM	2009-05-14
PMN K071702 BREAS MEDICAL AB	BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40	2008-02-15
PMN K063476 BREAS MEDICAL AB	BREAS ISLEEP 20I	2007-01-22
PMN K060657 BREAS MEDICAL AB	ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.	2006-08-18
PMN K061057 BREAS MEDICAL AB	BREAS ISLEEP 20+	2006-06-23
PMN K060546 BREAS MEDICAL AB	BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30	2006-05-26
PMN K060790 BREAS MEDICAL AB	BREAS, MODEL HA01	2006-05-25
PMN K053607 BREAS MEDICAL AB	BREAS VIVO 40 SYSTEM	2006-03-16

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202008286678	Bremerhaven,Federal Republic of Germany -> Boston, Massachusetts	TROLLEY	200 CTN
2020031659651	Tampico,Mexico -> Houston, Texas	PANASONIC MEXICO	1 PKG
2019102436569	Gothenburg,Sweden -> Boston, Massachusetts	MEDICAL EQUIPMENT	1 PKG
201910245327	Gothenburg,Sweden -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	1 PKG
2019100833768	Gothenburg,Sweden -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	1 PKG
2019100537925	Gothenburg,Sweden -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	1 PKG
2019100431585	Gothenburg,Sweden -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	1 PKG
2019092816898	Gothenburg,Sweden -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	1 PKG