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COALA LIFE AB

Matched from indexed company URL: Coala-Life AB

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30147453003014745300COALA LIFE AB1N2020-04-25Riddargatan 18 Stockholm Stockholms lan [SE-01] SE 11451

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
07350002700105Coala Heart Monitor US Rx - The Coala Heart Monitor is a medical device system that can be used by healthcareprofessionals for electrocardiogram (ECG) and digital auscultation (stethoscope) recordings.Persons with known or suspected heart conditions can use the Coala Heart Monitor to recordECG and heart sounds simultaneously for detection of normal sinus rhythm (NSR) and atrialfibrillation (AF) and to make these recordings available to their physician.9496366530carma.connely@coalalife.com
27350002700123Coala Heart Monitor US Rx - The Coala Heart Monitor is a medical device system that can be used by healthcare professionals for electrocardiogram (ECG) and digital auscultation (stethoscope) recordings. Persons with known or suspected heart conditions can use the Coala Heart Monitor to record ECG and heart sounds simultaneously for detection of normal sinus rhythm (NSR) and atrial fibrillation (AF) and to make these recordings available to their physician.9496366530carma.connely@coalalife.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2299671022044895K182040Coala Heart MonitorDXH2019-02-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXH12019-02-08

PMN#

GUDID#