Manufacturer

Natus

Canada, Denmark, Ireland, United StatesLegal entities : NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK), Natus Manufacturing Limited, Natus Medical Denmark ApS

First countries of placing on the market declared in EUDAMED : Austria, Denmark, France, Iceland, Ireland

Public contracts won : France 10, Ireland 2, Italy 2, Germany 1

EU representative : Natus Manufacturing Ltd (Ireland)

Website

24 categories, 89 models including 89 on the market, 4 countries

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Electromyography instruments - hardware accessories	Z12100480	2015 Visual Stimulator Only3 refs 842-2023002 refs Adhesive Electrodes3 refs Cart for Notebook PC Keypoint Class 1 Accessories (Hardware) Cart for Standard PC Keypoint Class 1 Accessories (Hardware) 13 others EDX Analog Output Box and Cable Extension Cable for Goggles Keypoint Class 1 Accessories2 refs Flex Arm with Clamp Keypoint Class 1 Accessories (Hardware) Natus Reflex Hammer Keypoint Class 1 Accessories Natus Tubal Insert Phones Keypoint Class 1 Accessories Natus Unshielded Headphones Keypoint Class 1 Accessories Nicolet EDX Amplifier Cables2 refs Nicolet LED Goggles RS10 Comfort Probe Kit3 refs Tendon Hammer Tremor Sensor Keypoint Class 1 Accessories (Hardware) UB4 Cart UB4 Cart Grounding Kit	I, IIb MDR	EUDAMED record Report an error
Audiometers	Z121401	1052 Otosuite Accessory 1066 Astera2 Accessories - Audiometer Control Panel (ACP)2 refs 1066 Astera2 Accessories - Headphones 1066 Astera2 Accessories - Insert Earphones 1066 Astera2 Accessories - Software 10 others 1066 MADSEN Astera 23 refs 1081 Aurical Aud3 refs 1081 Madsen A4503 refs AURICAL Loudspeaker 8‑62‑45200 Bone Conductor2 refs Foam Ear Tips 80A48209003 refs HB‑8 Headband (8 kHz) 8‑75‑4302 refs Headset ME70 (12 kHz) 8-75-7902 refs Headset ME70 (8 kHz) 8‑75‑770 Patient Responder3 refs	I, IIa MDR	EUDAMED record Report an error
General auditory and/or visual stimulators	Z129013	1077 Madsen Accuscreen3 refs Algo 3i 0107263 refs Echo SCreen III Accessories 0110103 refs Flexicouplers 0114453 refs Flexicouplers and Jelly Tab Sensors 20 PKG/60 Count Tab Electrode Package3 refs 5 others LED Photic Stim Plus Roll Stand (50 Hz) - 220V LED Photic Stim w/o Stand (50 Hz) - 220V3 refs Madsen Alpha3 refs OAE EarTips OAE EAR TIP3 refs Protektor32 Pods and Pod Kit P32 ACQ Pod combine kit3 refs Protektor32 Visual Stim LED Goggles	I, IIa MDR	EUDAMED record Report an error
Electroencephalographs	Z12100302	EMU40 Battery Pack Enclosure EMU40EX Class I Accessories2 refs EMU40EX with new Natus Base2 refs Lemo Patient call cord 2’3 refs Natus Base Unit3 refs Natus Quantum Patient Event Button 30 ft. (1.5 m)2 refs 2 others Natus Quantum Quantum (Phase II) 64-channel Breakout3 refs Olympic Brainz Monitor(OBM) OBM Viewer CD - V3.1.53 refs	I, IIa MDR	EUDAMED record Report an error
Electroencephalography instruments - hardware accessories	Z12100380	FHD IP PTZ Wall Mounted Camera Kit, INTL IP Alarm Controller Box Nicolet EEG Patient Event Button Quantum Breakout Roll stand Reusable Snap Lead Cable 0.6m (24"), (1.5mm DIN) Green, 1/pkg3 refs	I MDR	EUDAMED record Report an error
Paediatric phototherapy equipment	Z12080401	9-75-7702 refs neoBLUE Arm2 refs neoBLUE blanket LED Phototherapy System Light Box with power supply3 refs neoBLUE nova	I, IIa MDR	EUDAMED record Report an error
Video/electronystagmographs	Z12120124	1047 Face Cushion 1-25-136002 refs 1085 Face Cushion (10 Boxes/120 Cushions) 1085 ICS Impulse System3 refs 1085 ICS Impulse Vision Denied Solution 2 Kit (200 pcs) 0414812 refs 1091 ICS Dizcovery System3 refs	I, IIa MDR	EUDAMED record Report an error
Electromyographs	Z12100401	ErgoJust EMG Cart For Nicolet EDX NATUS TEMPERATURE PROBE ADAPTER UltraPro S1003 refs UltraPro UB3 Cart 0223302 refs	I, IIb MDR	EUDAMED record Report an error
Medical support equipment - accessories	V0880	External Battery Pack with Packaging2 refs Input Cables interconnecting with external devices3 refs Natus Quantum Breakout to Base Cable, 16 ft (5m)3 refs	I MDR	EUDAMED record Report an error
Electromyography instruments - consumables	Z12100485	Bo-ject DHN Disp Electrode, 1"(25mm)x0.30mm3 refs Disposable Injectable MyoJect Blue Luer Lock NEEDLE 50mm LG x 0.51mm, 10 per Pk3 refs	IIa MDR	EUDAMED record Report an error
Evoked potential audiometry instruments - hardware accessories	Z12140380	Protektor 32 Ear Inserts Protektor32 Auditory Stimulation Headphones	I MDR	EUDAMED record Report an error
Impedance meters for the auditory system	Z12149005	1096 Diagnostic Classic Probe 8-04-160303 refs Silicone Ear Tips 8-68-315143 refs	I, IIa MDR	EUDAMED record Report an error
Polysomnographs	Z12100501	Reusable Jumper Linker Cable3 refs Single Use Universal RIP Kit - Abdomen3 refs	I, IIa MDR	EUDAMED record Report an error
Polysomnography instruments - hardware accessories	Z12100580	Embla Bedside Unit Bracket3 refs ST / ST+ Proxy Interface Cable	I MDR	EUDAMED record Report an error
Direct outpatient otoscopes	Z12149006	OTOSCAN3 refs	I MDR	EUDAMED record Report an error
Direct outpatient video-otoscopes	Z12021009	Aurical Otocam 300-III3 refs	I MDR	EUDAMED record Report an error
EEG spectral analysers	Z12100301	Trex Ext. Battery Cable3 refs	I MDR	EUDAMED record Report an error
Electrode positioning systems for brain stimulation	Z12101102	Cortical Stimulator Control Unit3 refs	IIb MDR	EUDAMED record Report an error
Electroencephalography instruments - software accessories	Z12100382	NeuroWorks / SleepWorks Software NeuroWorks/SleepWorks 9.3.0 Installation Media (INTL)3 refs	IIa MDR	EUDAMED record Report an error
Endoscope transport carts	Z12029003	Protektor 32 trolley cart Protektor32 Trolley Cart	I MDR	EUDAMED record Report an error
Evoked potential audiometry instruments - consumables	Z12140385	Disposable Snap Electrodes3 refs	I MDR	EUDAMED record Report an error
Fluoroangiographs	Z12120105	RetCam Envision3 refs	I MDR	EUDAMED record Report an error
Patient positioning instruments - other	Z12011299	Vac-Pac3 refs	I MDR	EUDAMED record Report an error
Vestibular system analysis instruments - hardware accessories	Z12140480	1079 ICS Aircal 8-04-133213 refs	IIa MDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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