Manufacturer

Masimo

United StatesLegal entities : Masimo Corporation

First countries of placing on the market declared in EUDAMED : Germany

Public contracts won : France 53, Spain 19, Italy 4, Netherlands 1, Sweden 1

EU representative : MDSS GmbH (Germany)

Website customerorders@masimo.com

15 categories, 88 models including 88 on the market, 1 country

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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
Pulse oximeters	Z1203020408	Intellivue Module2 refs93/42 iSpO2 Rx , USB-C, Pediatric93/42 iSpO2 Rx, USB-C, Adult93/42 iSpO2 Rx, USB-C, RD93/42 Masimo SafetyNet 38 others Masimo SafetyNet, Radius PPG Chip3 refs Masimo SET SpO Cable, E30 uSpO293/42 Masimo SET SpO Cable, USB uSpO293/42 Masimo SET Module, LNC2 refs MightySat93/42 MightySat Rx6 refs Pronto3 refs93/42 Pronto, (DCI SC-200)93/42 Pronto, (DCI SC-200, DCIP SC-200)93/42 Pronto, (DCI SC-400)93/42 Pronto, (DCIP SC-200)93/42 Pronto, (DCIP SC-400)93/42 Rad-5 (Handheld)93/42 Rad-5 (Handheld, International)93/42 Rad-5 (Handheld, Refurbished)93/42 Rad-5 (Handheld, with Sensor Sample Pack)93/42 Rad-576 refs93/42 Rad-57c93/42 Rad-57cm2 refs93/42 Rad-5v (Handheld)93/42 Rad-5v (Handheld, International)93/42 Rad-5v (Handheld, Refurbished)93/42 Rad-5v (Handheld, with Sensor Sample Pack)93/42 Rad-5v Handheld, DCI, DCI-P93/42 Rad-5v Handheld, Pediatric93/42 Rad-67, Pulse CO-Oximeter (Spot-check) Rad-G5 refs Radius PPG Kit, M202 refs Radius PPG Wireless Receiver93/42 rainbow SET COOximetry Module rainbow SET Module Carescape2 refs93/42 rainbow SET IntelliVue Module2 refs93/42 Rainbow Set Module93/42 Rainbow Set Module for Welch Allyn93/42 rainbow SET Pulse CO-Oximetry Cable, Carescape Sp02, Masimo, 0.9m Cable93/42 rainbow SET Pulse CO-Oximetry Cable, GE Carescape Sp02, Masimo93/42 uSpO2 Pulse Oximetry Cable for GE ApexPro CH, CARESCAPE Telemetry T4 & T143 refs uSpO2 Masimo SET Oximetry Cable6 refs93/42 uSpO2 Masimo SET Oximetry Cable, USB93/42	IIb MDR, 93/42	EUDAMED record Report an error
Transportable/portable multi-parameter patient monitors	Z1203020202	Masimo W1 Rad-972 refs Rad-97 Home Use with noninvasive blood pressure2 refs Rad-97 with NomoLine Capnography Radical-72 refs 5 others Radius VSM - ECG Electrode Adult 3-Lead3 refs Radius VSM Disposable NIBP Cuff3 refs Radius VSM Monitor Radius VSM with Reusable Pod & NIBP Radius-72 refs93/42	IIb MDR, 93/42	EUDAMED record Report an error
Multi-parameter monitors - hardware accessories	Z1203020280	LNC MAC-GE3 refs LNCS to RD Adapter Cable3 refs M-LNC MAC CMS3 refs M-LNC MP103 refs Radical Docking Station3 refs 3 others RAM Dual Cable, LNC M20-103 refs RD SET MD20 - 053 refs SPO2.COM NRC-180 SpO2.com Cables3 refs	I, IIb MDR	EUDAMED record Report an error
Gaseous exchange monitoring instruments - other	Z1203020499	IRMATM AX+ IRMA AX+3 refs93/42 IRMATM CO2 IRMA CO26 refs93/42 NomoLine ISA AX+3 refs NomoLine ISA OR+3 refs	IIb MDR, 93/42	EUDAMED record Report an error
Electroencephalographs	Z12100302	SedLine2 refs93/42 SedLine Module2 refs93/42 smartSedLineTM Sedatoin Monitor2 refs	IIb MDR, 93/42	EUDAMED record Report an error
Gaseous exchange monitoring instruments - hardware accessories	Z1203020480	IRMA Airway Adapter AduIt/Pediatric93/42 IRMA Airway Adapter Infant93/42 ISA Gas Exhaust Kit	I, IIa MDR, 93/42	EUDAMED record Report an error
Polygraphy systems for haemodynamic studies	Z12050702	LiDCO Module2 refs LiDCO to B. Braun, BP Module Cable3 refs LiDCO to BNC, Analog Cable3 refs	I, IIb MDR	EUDAMED record Report an error
Vital signs monitoring instruments - consumables	Z12030285	RAS-125c RAS Sensors93/42 RAS-125c, Adult/Pediatric Acoustic Respiration Cloth Sensor (RRa)2 refs RAS-45 Inf/Neo rainbow Acoustic Sensor, Masimo3 refs	IIb MDR, 93/42	EUDAMED record Report an error
Cerebral oximeters	Z1203020406	O3 Regional Oximeter3 refs O3 Sensors2 refs	IIb MDR	EUDAMED record Report an error
Contact digital thermometers (including probes)	V0301010201	Radius T93/42 Radius T° for Masimo SafetyNet93/42	IIa 93/42	EUDAMED record Report an error
Multi-parameter monitors - medical device software	Z1203020292	Patient SafetyNet Patient SafetyNet Lite	IIb MDR	EUDAMED record Report an error
Multi-parameter patient bedside monitors	Z1203020201	Root, Masimo93/42 Root, NIBP and Temperature	IIb MDR, 93/42	EUDAMED record Report an error
Carbon dioxide analysers	Z1203020401	EMMA Capnograph kPa3 refs	IIb MDR	EUDAMED record Report an error
Electroencephalography instruments - hardware accessories	Z12100380	RD SedLine3 refs	I MDR	EUDAMED record Report an error
Various instruments to support and monitor vital signs - consumables	Z12039085	Centroid	IIa MDR	EUDAMED record Report an error

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