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Natus Manufacturing Limited

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30055812703005581270Natus Manufacturing Limited1N2026-01-01IDA BUSINESS PARK GORT, Co. Galway IE --

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1501501296659478K973442TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODESIKT1997-11-20
1501501240214993K971914TECA NCS ELECTRODE SYSTEM 2000GXY1998-03-26
1501501847126981K944547DANTEC KEYPOINTGWF1995-09-19
1501501095180731K934580DANTEC 13R45 BAR ELECTRODEGXY1994-09-26
1501501759679407K874735DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODEGXY1988-01-22
1501501091565059K850108EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEGGXY1985-04-11
1501501826724613K243495Natus Ultrapro S100 (982A0594)GWF2024-12-12
1501501967963818K242346Grass® MR Conditional/CT Cup ElectrodesGXY2024-08-29
1501501684267904K173815Allergan Botox Needle ElectrodeIKT2018-06-29
1501501409301406K161430Myoject Luer Lock Needle ElectrodeIKT2017-03-02
1501501636192603K143433Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mmIKT2015-08-28
1501501979589814K140680LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEMGZL2014-12-12
1501501657161547K132110NATUS WARMETTE BLANKET AND DUAL CABINETSLGZ2013-10-03
1501501319318100K112034TECA ELITE DISPOSABLE CONCENTRIC NEEDLESIKT2011-08-12
1501501007814735K111131TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLESIKT2011-06-17
1501501553086521K062478CLAVISBXN2007-02-08
1501502020694240K043132UNIVERSAL XACTTRACEMNR2004-12-21
1501501300883934
1501501089160083
1501501130145320
1501501133926893
1501501156966802
1501501186158155
1501501204011015
1501501251661732
1501501334070799
1501501420828792
1501501460152040
1501501472913548
1501501478777801
1501501528111313
1501501586415305
1501501626415462
1501501649783005
1501501687671386
1501501693112397
1501501906472737
1501501951147570
1501501964242879

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GXY62024-08-29
IKT62018-06-29
GWF22024-12-12
GZL12014-12-12
LGZ12013-10-03
BXN12007-02-08
MNR12004-12-21

PMN#

GUDID#

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