FDA.reportPublic FDA data

Natus Medical Denmark ApS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96121973002807554Natus Medical Denmark ApS1N2026-01-01Hoerskaetten 9 TAASTRUP Hovedstaden DK DK-2630
96121973002807554Natus Medical Denmark ApS1N2020-04-25Hoerskaetten 9 TAASTRUP Region Hovedstaden DK DK-2630

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
161202022107491K910247ZODIAC 901 MIDDLE-EAR ANALYZERETY1991-06-19
3390081750919494K242198ICS Dizcovery (1091)GWN2025-02-14
3390081059094408K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)GWJ2024-03-08
3390081509260693K203500RetCam EnvisionHKI2021-04-13
3390081708243813K182178neoBLUE blanket LED Phototherapy SystemLBI2018-12-13
161201124322176K161707Madsen ZodiacETY2016-09-01
3390081487501581K161707Madsen ZodiacETY2016-09-01
3390081921649998K160745neoBLUE compact LED Phototherapy SystemLBI2016-12-12
3390081251971318K160305neoBLUE® LED Phototherapy SystemLBI2016-05-27
3390081607419408K151504ICS ImpulseGWN2015-11-16
3390081790566845K141446ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,GWJ2014-08-22
3390081449752607K132957MADSEN ACCUSCREEN TYPE 1077GWJ2014-02-27
161202048193824K132957MADSEN ACCUSCREEN TYPE 1077GWJ2014-02-27
161201587731646K122550ICS IMPULSEGWN2013-02-01
3390081708415446K122550ICS IMPULSEGWN2013-02-01
3390081106816766K122067TYPE 1077 ACCUSCREENGWJ2012-09-27
161201200497123K122067TYPE 1077 ACCUSCREENGWJ2012-09-27
161201178071435K122028AURICAL HITETW2012-10-23
3390081494341921K122028AURICAL HITETW2012-10-23
3390081129943728K110286GN OTOMETRICS TYPE 1053 FREEFITETW2011-04-28
161201500337505K110286GN OTOMETRICS TYPE 1053 FREEFITETW2011-04-28
161201263221500K083399ICS CHARTR EP 200GWJ2009-02-20
161201643222872K081234GN OTOMETRICS INSERT EARPHONESEWO2008-07-14
3390081965088206K081234GN OTOMETRICS INSERT EARPHONESEWO2008-07-14
3390081336256371K073665ALGO 5 NEWBORN HEARING SCREENERGWJ2008-01-25
161201838621029K061791FOCUS VNG/ENG TYPE 1068GWN2006-07-11
161201939907511K061443SMART USBLITE, MODEL M011120GWJ2006-06-23
161201186499806K033645OTOFLEX 100 TYE 1012ETY2004-03-31
3390081522937231K033645OTOFLEX 100 TYE 1012ETY2004-03-31
3390081945818759K030823ALGO 3I NEWBORN HEARING SCREENERGWJ2003-04-09
161201354773372K002200CAPELLAEWO2000-08-25
161201268360409
161201631352857
161201783479027
161201831970984
161201981314850
3390081357683372
3390081556901348
3390081604809084
3390081677190307
3390081770349489
3390081839351146

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GWJ102024-03-08
GWN52025-02-14
ETY52016-09-01
ETW42012-10-23
LBI32018-12-13
EWO32008-07-14
HKI12021-04-13

GUDID#

200 records. Showing 1-40. Next