FDA.reportPublic FDA data

BREAS MEDICAL AB

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96175663003244771BREAS MEDICAL AB1N2026-01-01FORETAGSVAGEN 1 MOLNLYCKE Vastra Gotaland SE 435 33

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07321820048915Vivo 50 - Nurse Call Cable NO855-436-8724supportUS@breas.com
07321820048922Vivo 50 - Nurse Call Cable NC855-436-8724supportUS@breas.com
07321820048939Vivo 50 - Nurse Call Cable NO, 10 KOhm855-436-8724supportUS@breas.com
07321820048946Vivo 50 - Nurse call cable NC, 10K Ohm855-436-8724supportUS@breas.com
07321820048960Vivo 50 - Remote alarm cable 10m855-436-8724supportUS@breas.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1682861235685433K242485EveryWareMOD2025-05-20
1682862011056865K242438ClearoNHJ2025-05-16
1682861182748276K240779Vivo 3MNT2024-12-13
1682861104875660K240778Vivo 1, Vivo 2MNS2024-12-13
1682862038521984K233452Vivo 45 LSNOU2025-01-13
1682861970995652K232365Vivo 45 LSCBK2025-12-19
1682861924236087K193586Vivo 45 LSNOU2021-01-27
1682861032319922K160481Vivo 60NOU2016-11-09
1682861952652721K123144VIVO 50NOU2013-06-18
1682861534778808K090113BREAS VIVO 40 SYSTEMMNT2009-05-14
1682861995009662K071702BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40MNT2008-02-15
1682861620896041K063476BREAS ISLEEP 20IBZD2007-01-22
1682861852640632K061057BREAS ISLEEP 20+BZD2006-06-23
1682861454098848K060790BREAS, MODEL HA01BTT2006-05-25
1682861758295205K060657ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.BZD2006-08-18
1682861183021100K060546BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30MNS2006-05-26
1682861998479399K053607BREAS VIVO 40 SYSTEMMNT2006-03-16
1682861029908228K051559IMASK, MODELS 100, 200 AND 300BZD2005-07-08
1682861181551604K041309IMASK TMBZD2004-06-30
1682861300737548K030985BREAS PV 10I CPAP SYSTEM, MODEL PV 10IBZD2003-10-15
1682861628693393K002454BREAS HA50 HUMIDIFIER, MODEL HA50BTT2001-03-07
1682861407314499K002384M-XX OXYGEN SENSORSCCL2000-12-15
1682861580437408K001553BREAS PV 100 CPAP SYSTEMBZD2000-08-03
1682861011509352
1682861888397171
1682861982427548

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BZD72007-01-22
NOU42025-01-13
MNT42024-12-13
MNS22024-12-13
BTT22006-05-25
CBK12025-12-19
MOD12025-05-20
NHJ12025-05-16
CCL12000-12-15

PMN#

Vivo 3

2024-12-13

Breas Medical AB

GUDID#

130 records. Showing 1-40. Next