Natus Medical Denmark A P S

FDA Filings

This page includes the latest FDA filings for Natus Medical Denmark A P S. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9612197
FEI Number3002807554
NameNatus Medical Denmark ApS
Owner & OperatorGN OTOMETRICS A/S
Contact Address2568 Bristol Circle
Oakville CA-ON Ontario L6H 5S1 CA
Official Correspondent
  • Sanjay - Mehta
  • 1-905-2875055-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressHoerskaetten 9
TAASTRUP Region Hovedstaden, DK-2630 DK
Establishment Type
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device
Company
DeviceDate
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Zodiac insert phone2016-09-04
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Probe tips2016-09-04
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
MADSEN Zodiac SA Quick Check w/o printer2016-09-04
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
MADSEN Zodiac SA Quick Check w/ printer2016-09-04
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
MADSEN Zodiac SA Diagnostic w/o printer2016-09-04
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
MADSEN Zodiac SA Diagnostic w/ printer2016-09-04
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
MADSEN Zodiac SA Clinical w/o printer2016-09-04
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
MADSEN Zodiac SA Clinical w/ printer2016-09-04
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
MADSEN Zodiac PC Quick Check2016-09-04
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
MADSEN Zodiac PC Diagnostic2016-09-04
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
MADSEN Zodiac PC Clinical2016-09-04
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Contra TDH392016-09-04
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
1096 Probe, Diagnostic2016-09-04
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1077 - MADSEN Alpha OAE2014-05-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1077 - MADSEN Aipha OAE+2014-05-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Small tip kit2014-05-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Alpha starter kit2014-05-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Capella22013-06-12
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Capella22013-06-12
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Capella22013-06-12
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Vision denied solution kit2013-02-14
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1085 - ICS Impulse2013-02-14
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Strap assembly2013-02-14
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
ICS impulse face cushion kit2013-02-14
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
ICS Monocular VNG Video/oculd/Posit kit (US Version)2013-02-14
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
ICS Impulse Monocular Video Frenzel2013-02-14
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Goggle face cushion kit2013-02-14
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
1085 USB Goggle Full upgrade2013-02-14
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Vision denied solution kit2013-02-14
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1085 - ICS Impulse2013-02-14
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Strap assembly2013-02-14
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
ICS impulse face cushion kit2013-02-14
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
ICS Monocular VNG Video/oculd/Posit kit (US Version)2013-02-14
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
ICS Impulse Monocular Video Frenzel2013-02-14
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Goggle face cushion kit2013-02-14
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
1085 USB Goggle Full upgrade2013-02-14
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1082 - Aurical HIT2012-10-30
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Reference microphone2012-10-30
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Coupler microphone2012-10-30
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1077 ? MADSEN AccuScreen TE2012-10-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1077 ? MADSEN AccuScreen TE/DP2012-10-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1077 ? MADSEN AccuScreen DP2012-10-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1077 ? MADSEN AccuScreen ABR2012-10-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1077 ? MADSEN AccuScreen ABR/TE2012-10-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1077 ? MADSEN AccuScreen ABR/TE/DP2012-10-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1077 ? MADSEN AccuScreen ABR/DP2012-10-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Otometrics Ear couplers, disposables2012-10-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Foamtip 6-10 mm yellow foam2012-10-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Electrodes, snap, disposables2012-10-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip yellow 4-7 mm tree2012-10-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 5.5mm transparent blue2012-10-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 5.0 mm pastel blue2012-10-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 4.5 mm red brown2012-10-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 4.5 mm pastel pink2012-10-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 4.0 mm pastel green2012-10-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 4.0 mm dark blue2012-10-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 4-7 mm tree transparent2012-10-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 3.7 mm pastel yellow2012-10-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Earhugs, disposables2012-10-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Acoustic filters2012-10-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Acccuscreen starter kit2012-10-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1079 - ICS Aircal2012-06-21
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Specula, disposable2012-06-21
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1053 - FreeFit2011-05-30
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1053 - AVS2011-05-30
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
REM Tubes, Blue handle2011-05-30
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
RECD Fitting Kit2011-05-30
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
RECD Eartip Kit2011-05-30
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Probe Tube Holder mk22011-05-30
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
PMM RECD Probe long2011-05-30
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
PMM RECD Probe Short2011-05-30
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
PMM RECD Probe BIN Short2011-05-30
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
PMM RECD Probe BIN Long2011-05-30
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
OTOair Bluetooth Dongle2011-05-30
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
OTOair 2 Bluetooth Dongle2011-05-30
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
FreeFit REM Probe2011-05-30
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1073 - Chartr EP 2002009-09-02
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Insert Phone, 300 OHM, 1,2M, MATCH2009-09-02
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Disposable Diff VEMP Electrode2009-09-02
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Chartr EP 200 VEMP Moniter Kit2009-09-02
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
1073 TDH-49 Earphone With Cable2009-09-02
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
1073 Five electrode package 9 mm deep cup 48"2009-09-02
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
1073 Bone Conduction Transducer Kit2009-09-02
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type Capella - Capella2009-03-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip, box2009-03-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1078 - OtoInsert2008-08-13
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Insert Earphone Tubing with tip2008-08-13
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Insert Earphone Tubing with impedance adaptor2008-08-13
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Insert Earphone Tube Tips2008-08-13
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Foam Tip (Mixed Bag)2008-08-13
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1068 - Focus VNG/ENG2008-08-13
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1068 - Chartr 2002008-08-13
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
ICS VG40, Video Goggle VNG2008-08-13
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Headstrap2008-08-13
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
FACE CUSHION2008-08-13
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Disposable Electrode Snap2008-08-13
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Disposable Electrode 24" Wired2008-08-13
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
1068 ICS, ENG 4 CH Kit2008-08-13
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
1068 ICS, ENG 2 CH Kit2008-08-13
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
1068 ICS Chartr 200 Light Bar2008-08-13
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
1068 Chartr 200 VNG/ENG 2 CH2008-08-13
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1075 - Balance Platform2008-03-10
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
probe assembly w. 3 tubes2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
earphone pad2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
ZO901 probe handle2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type Zodiac - Zodiac 9012008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
TDH 39 with cushion (contralateral earphone)2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
TDH 39 contra add-on set2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Insert Phone, 10 Ohm, Mini jack2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip, ZO901 22 mm2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip, ZO901 19 mm2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip, ZO901 16 mm2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip, ZO901 13 mm2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip, ZO901 10 mm2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip, 9,5 mm2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip, 8 mm2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip, 14 mm2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip, 11 mm2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip kit with 14 different eartips from 6 mm - 22 mm2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 16 mm2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 12.5 mm2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Adult probeset with contra insert, insert earphone 10 OHM, SPL. calibration: SPL2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Adult probeset with contra insert, insert earphone 10 OHM, HL. calibration: HL2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Adult headset with TDH, SPL calibration: SPL2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Adult headset with TDH, HL calibration: HL2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Adult IPSI probeset, SPL. Calibration: SPL2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Adult IPSI probeset, HL. Calibration: HL2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
wax filter kit2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1012 - Otoflex 1002008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Set of probe tips and locking nuts2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Immitance probe 180 cm. Completed2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip Box, Large2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 9,5mm, semi blue (tree dip)2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 8mm, semi green (tree tip)2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 7mm, semi red (tree tip)2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 6mm, semi grey (tree tip)2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 5mm, blue (tree tip)2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 4mm, green (tree tip)2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 3mm, grey (tree dip)2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 18mm, semi grey (tree tip)2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 16mm, semi blue (tree tip)2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 14mm, semi green (tree tip)2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 12,5mm, semi red (tree tip)2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 11mm, semi grey (tree tip)2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 10mm, transparent (tree tip)2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
EAR tone 3A - Contra Insert Phone2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
22 mm, transparent2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
19 mm, transparent2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
16 mm, transparent2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
13 mm, transparent2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1093 - Otoscan2008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1076 - OTOcam 3002008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Specula, 3mm, normal, 122008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Specula, 3mm, cerumen, 122008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
1093, HEADSET HS32008-02-06
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1081 - Aurical Aud2001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1081 - Aurical Aud with built in HI-PRO 22001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1081 - A4502001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1067 - Xeta2001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1066 - Astera2001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1066 - Astera 22001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1004 - Itera II2001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Stereo Microphone2001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
REM Tubes2001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Patient signal, red2001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Patient signal, grey2001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Patient signal, Blue2001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Patient Responder (Blue)2001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Monitor Speaker Kit2001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Insert earphone, mono2001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Insert earphone 10 Ohm2001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Headset TDH 39 with HB-7 headband2001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Headset ME 702001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Headset Holmco2001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Headset HDA-3002001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Eartip 3A , jumbo2001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Cable for 5 Speaker - RCA line out2001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Cable for 2 Speaker - RCA line out2001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
B71 Bone conductor w. Headband2001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Accessory ad on kit incl. 8-72-1402001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
1081, Loudspeaker2001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type Noahlink - Noahlink2001-08-08
Natus Medical Denmark ApS [GN OTOMETRICS A/S]
Type 1072 - HI-PRO 22001-08-08

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