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NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK)

Canada·CA-MF-000004001

Last updated September 18, 2026

Information

Country: Canada
Address: 2568, Bristol Cricle, Oakville, Canada
Website: www.natus.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 905 287 5055
PRRC Contact: Sanjay Mehta
EUDAMED SRN: CA-MF-000004001
FDA FEI Number: —
DUNS Number: —

Catalogue (182)

Page 1 of 4

Device	Model / Reference	Registries	Class	Status
NeuroWorks / SleepWorks Software	041907	EUDAMED	Class IIa	Active
Quantum Breakout Roll stand	017264	EUDAMEDFDA UDI	Class I	Active
Natus Quantum	016278	EUDAMEDFDA UDI	Class IIa	Active
XactTrace belt - Pediatric	011516	EUDAMEDFDA UDI	Class IIa	Active
Trex HD Headbox Monitoring	019245	EUDAMEDFDA UDI	Class I	Active
Protektor32 Pods and Pod Kit	017882	EUDAMEDFDA UDI	Class I	Active
Protektor32 Pods and Pod Kit	003040	EUDAMED	Class I	Active
Protektor32 Pods and Pod Kit	002510	EUDAMEDFDA UDI	Class I	Active
Patient Events Button 8’	W6232H	EUDAMEDFDA UDI	Class I	Active
Natus Quantum	016271	EUDAMEDFDA UDI	Class IIa	Active
Olympic Brainz Monitor(OBM)	OBM00410	EUDAMEDFDA UDI	Class IIa	Active
Protektor32 Pods and Pod Kit	017867	EUDAMEDFDA UDI	Class I	Active
Input Cables interconnecting with external devices	013790	EUDAMEDFDA UDI	Class I	Active
Protektor32 Pods and Pod Kit	002500	EUDAMEDFDA UDI	Class I	Active
Reusable Snap Lead Cable 0.6m (24"), (1.5mm DIN) Green, 1/pkg	1411548	EUDAMEDFDA UDI	Class I	Active
XactTrace Lock Abdomen EBG	1421021	EUDAMEDFDA UDI	Class IIa	Active
Protektor32 Pods and Pod Kit	017847	EUDAMEDFDA UDI	Class I	Active
Neonatal Hydrogel Sensor	OBM00047	EUDAMEDFDA UDI	Class I	Active
External Battery Pack Power Supply	019755	EUDAMEDFDA UDI	Class I	Active
Reusable Snap Lead Cable 0.6m (24"), (1.5mm DIN) Red, 1/pkg	1411541	EUDAMEDFDA UDI	Class I	Active
Reusable Snap Lead Cable 3.0m (120"), (1.5mm DIN) White, 2/pkg	1411530	EUDAMEDFDA UDI	Class I	Active
Trex HD Monitoring	PK1055HDM	EUDAMEDFDA UDI	Class I	Active
Protektor32 Pods and Pod Kit	017866	EUDAMEDFDA UDI	Class I	Active
P PTZ HD ErgoJust Video Extension	IP-HD-EC-VIDEO-EXT	EUDAMEDFDA UDI	Class I	Active
Reusable Snap Lead Cable 1.0m (39"), (1.5mm DIN) Orange, 2/pkg	1411517	EUDAMEDFDA UDI	Class I	Active
Reusable Snap Lead Cable 1.0m (39"), (1.5mm DIN) Green, 1/pkg	1411516	EUDAMEDFDA UDI	Class I	Active
Protektor32 Pods and Pod Kit	002507	EUDAMEDFDA UDI	Class I	Active
XLTEK EMU40EX EEG Headbox	K163163	FDA 510(k)	Class II	Active
Background Pattern Classification [BPc(TM)]	K152301	FDA 510(k)	Class II	Active
Grass TWin	K173690	FDA 510(k)	Class II	Active
Comet-PLUS	K172711	FDA 510(k)	Class II	Active
Natus BrainWatch System	K242930	FDA 510(k)	Class II	Active
RetCam Envision	K203500	FDA 510(k)	Class II	Active
ALGO Pro Newborn Hearing Screener (ALGO Pro)	K233649	FDA 510(k)	Class II	Active
Trex_HD	K162595	FDA 510(k)	Class II	Active
Natus Brain Monitor Amplifier	K180290	FDA 510(k)	Class II	Active
Protektor32 Pods and Pod Kit	017870	EUDAMEDFDA UDI	Class I	Active
Protektor32 Pods and Pod Kit	017848	EUDAMEDFDA UDI	Class I	Active
Supplies, Value Pack, Algo	040670	EUDAMED	Class I	Active
XactTrace Extension Cable Thorax 78in/200cm	1451072	EUDAMEDFDA UDI	Class IIa	Active
Vac-Pac	51635	EUDAMEDFDA UDI	Class I	Active
Protektor32 Pods and Pod Kit	017846	EUDAMEDFDA UDI	Class I	Active
Protektor32 Pods and Pod Kit	002506	EUDAMEDFDA UDI	Class I	Active
Protektor32 Pods and Pod Kit	002508	EUDAMEDFDA UDI	Class I	Active
Supplies Pack, Algo	040546	EUDAMED	Class I	Active
OBM positioning strips	OBM00042	EUDAMED	Class I	Active
Vac-Pac Cover	VPC40	EUDAMEDFDA UDI	Class I	Active
Natus Quantum	016269	EUDAMEDFDA UDI	Class IIa	Active
Natus Quantum	014165	EUDAMEDFDA UDI	Class IIa	Active
Natus Reusable Snap Leads and Natus Disposable Snap Electrodes	1410500	EUDAMEDFDA UDI	Class I	Active

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