Manufacturer

Nonin

United StatesLegal entities : Nonin Medical, Inc.

Markets : Netherlands · United States

Approvals : EU – class IIb · United States (FDA) – 510(k) : 50 · class I, II · latest in 2024 · see on the FDA website

EU representative : MPS Medical Product Service GmbH (Germany)

regulatory@nonin.com

1 category, 152 models including 152 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	Avant Pulse Oximeter System MODEL 9600, 8000AA, PCS-EU93/42 Avant Pulse Oximeter System MODEL 9600, 8000AA, PCS-US93/42 Avant Pulse Oximeter System MODEL 9600, 8000AA-2, PCS-EU93/42 Avant Pulse Oximeter System MODEL 9600, 8000AA-2, PCS-US93/42 Avant Pulse Oximeter System MODEL 9600, 8000J, PCS-EU93/42 147 others Avant Pulse Oximeter System MODEL 9600, 8000SL, PCS-US93/42 Avant Pulse Oximeter System MODEL 9600, 8000SL-3, PCS-US93/42 Avant Pulse Oximeter System MODEL 9600, 8000SM, PCS-EU93/42 Avant Pulse Oximeter System MODEL 9600, 8000SM-3, PCS-EU93/42 Avant Pulse Oximeter System MODEL 9600, 8000SS-3, PCS-EU93/42 Avant Pulse Oximeter System MODEL 9600, 8008J, PCS-EU93/42 Avant Pulse Oximeter System MODEL 9600, PULSE OXIMETER HC93/42 Avant Pulse Oximeter System with Waveform MODEL 9700, 8000AA-3, PCS-US93/42 Avant Pulse Oximeter System with Waveform MODEL 9700, 8000SL-3, PCS-US93/42 Avant Pulse Oximeter System with Waveform MODEL 9700, 8000SM-3, PCS-US93/42 Avant® 9600 Pulse Oximeter MODEL 9600, 8000AA-3, PCS-EU93/42 Avant® 9600 Pulse Oximeter MODEL 9600, 8000AA-3, PCS-US93/42 Avant® 9600 Pulse Oximeter MODEL 9600, 8000SM-3, PCS-UK93/42 Fiber Optic Pulse Oximeter MODEL 7500FO, PCS-JP93/42 Fiber Optic Pulse Oximeter MODEL 7500FO, PULSE OXIMETER, INMETRO93/42 Fingertip Pulse Oximeter MODEL 9590, OXIMETER - BLACK, INMETRO93/42 FINGERTIP PULSE OXIMETER with 9590 BLUE, OXIMETER MODEL 9590 BLUE, OXIMETER93/42 FINGERTIP PULSE OXIMETER with 9590 RED, OXIMETER MODEL 9590 RED, OXIMETER93/42 FINGERTIP PULSE OXIMETER, MODEL 9590 BLK, OXIMETER93/42 Flexiwrap Adhesive Strips 70276, MODEL 8000JFW ADULT FLEXW DISP93/42 LP XPOD 22370, XPOD LP - 8000SM SENSOR SET93/42 LP XPOD 22380, XPOD LP - 7000A SENSOR SET93/42 LP XPOD 36944, XPOD LP - 8000SM-3M SENSOR SET93/42 Model 2500 PKG ASSY, 2500, CHINA93/42 MODEL 2500, PALMSAT HANDHELD OXIMETER93/42 MODEL 3011LP XPOD, OXIMETER DF1 2M W/O CONN93/42 MODEL 3011LP XPOD, OXIMETER DF1 W/O CONN93/42 MODEL 3012LP, LP XPOD93/42 MODEL 3017LP XPOD, OXIMETER DF7 W/OUT CONN93/42 MODEL 3150SC, WRIST-OX2 USB COMM CABLE93/42 Model 3231 USB OEM External Pulse Oximeter93/42 MODEL 7500, 8000SL, PCS-USPulse Oximeter System93/42 Model 9550 Onyx II Fingertip Pulse Oximeter System 6515-01-535-2728, OXIMETER, PULSE, FINGER W/CASE93/42 MODEL 9590, OXIMETER BLUE93/42 MODEL 9590, OXIMETER RED93/42 MODEL LP XPOD, ALICE NIGHTONE, NONIN SPO2 CAB93/42 MODEL LP XPOD, NONIN, SPO2 CABLE, ALICE93/42 MODEL X-100H, HUB93/42 MODEL X-100HH, HUB HOLSTER93/42 Multi-Sensing Oximetry Signal Processor MODEL 3500SP, DEVELOPMENT KIT93/42 NoninConnect Elite Finger Pulse Oximeter MODEL 3240, NONINCONNECT ELITE93/42 OEM External Pulse Oximeter MODEL 323193/42 OEM External Wireless Pulse Oximeter MODEL 3230, V2.7 AU/NZ93/42 OEM External Wireless Pulse Oximeter PKG ASSY, 3230, CONTINUA93/42 Onyx II Fingertip Pulse Oximeter MODEL 9550, PULSE OXIMETER93/42 Onyx® Vantage 9590 Fingertip Pulse Oximeter MODEL 9590, OXIMETER BLACK93/42 Onyx® Vantage 9590 Fingertip Pulse Oximeter MODEL 9590, OXIMETER PURPLE93/42 PalmSAT Charger MODEL 2500C, PCS-JP93/42 PalmSAT Charger MODEL 2500C, PULSE OXIMETER CHARGER, INMETRO93/42 PALMSAT HANDHELD OXIMETER MODEL 2500, 8000Q293/42 PALMSAT HANDHELD OXIMETER MODEL 2500A CFG, PULSE OXIMETER W/ALARMS93/42 PALMSAT HANDHELD OXIMETER MODEL 2500A, PULSE OXIMETER W/ALARMS93/42 PALMSAT HANDHELD OXIMETER with 8000J sensor MODEL 2500, 8000J93/42 PALMSAT HANDHELD OXIMETER with 8001J sensor MODEL 2500, 8001J93/42 PalmSat Pulse Oximeter System MODEL 2500, 8000AA-293/42 PalmSat Pulse Oximeter System MODEL 2500, 8000AA-393/42 PalmSat Pulse Oximeter System MODEL 2500, 8000AP93/42 PalmSat Pulse Oximeter System MODEL 2500, 8000AP-393/42 PalmSat Pulse Oximeter System MODEL 2500, 8000J-393/42 PalmSat Pulse Oximeter System MODEL 2500, 8000SL-393/42 PalmSat Pulse Oximeter System MODEL 2500, PALMSAT HANDHELD OXIMETER CONFIGUREABLE93/42 PalmSat Pulse Oximeter System MODEL 2500A INMETRO, 8000SM-393/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000AA-293/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000AP-393/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000J93/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000Q293/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000SL93/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000SL-393/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000SS93/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000SS-393/42 PalmSat Pulse Oximeter System MODEL 2500A, 8008J93/42 Pulse Oximeter System MODEL 2500, 8000SS-393/42 Pulse Oximeter System MODEL 7500 INMETRO, 8000SM-393/42 Pulse Oximeter System MODEL 7500, 8000AA, PCS-AU93/42 Pulse Oximeter System MODEL 7500, 8000AA, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8000AA, PCS-UK93/42 Pulse Oximeter System MODEL 7500, 8000AA, PCS-US93/42 Pulse Oximeter System MODEL 7500, 8000AA-2, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8000AA-2, PCS-UK93/42 Pulse Oximeter System MODEL 7500, 8000AA-2, PCS-US93/42 Pulse Oximeter System MODEL 7500, 8000AA-3, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8000AA-3, PCS-UK93/42 Pulse Oximeter System MODEL 7500, 8000AA-3, PCS-US93/42 Pulse Oximeter System MODEL 7500, 8000AA-3M, PCS-AU93/42 Pulse Oximeter System MODEL 7500, 8000AP, PCS-AU93/42 Pulse Oximeter System MODEL 7500, 8000AP, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8000AP-3, PCS-AU93/42 Pulse Oximeter System MODEL 7500, 8000J, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8000Q2, PCS-US93/42 Pulse Oximeter System MODEL 7500, 8000SL, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8000SL-3, PCS-UK93/42 Pulse Oximeter System MODEL 7500, 8000SM, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8000SM-3, PCS-AU93/42 Pulse Oximeter System MODEL 7500, 8000SM-3, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8000SM-3, PCS-UK93/42 Pulse Oximeter System MODEL 7500, 8000SM-3, PCS-US93/42 Pulse Oximeter System MODEL 7500, 8000SS, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8000SS, PCS-US93/42 Pulse Oximeter System MODEL 7500, 8000SS-3, PCS-AU93/42 Pulse Oximeter System MODEL 7500, 8000SS-3, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8000SS-3, PCS-UK93/42 Pulse Oximeter System MODEL 7500, 8001J, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8001J, PCS-UK93/42 Pulse Oximeter System MODEL 7500, 8001J, PCS-US93/42 Pulse Oximeter System MODEL 7500, 8008J, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8008J, PCS-US93/42 Pulse Oximeter System MODEL 7500, NO SENSOR, PCS-AU93/42 Pulse Oximeter System MODEL 7500, PULSE OXIMETER HC93/42 Pulse Oximeter with Waveform MODEL 9700, 8000AA, PCS-EU93/42 SenSmart X-100 MODEL X-100SP-1, SENSMART SIGNAL PROCESSOR93/42 SenSmart X-100 MODEL X-100SP-2, SENSMART SIGNAL PROCESSOR93/42 SenSmart X-100 MODEL X-100SP-3, SENSMART SIGNAL PROCESSOR93/42 SenSmart X-100 MODEL X-100SP-4, SENSMART SIGNAL PROCESSOR93/42 SenSmart X-100 MODEL X-100SP-6, SENSMART SIGNAL PROCESSOR93/42 Universal Oximetry System MODEL X-100, INT, PCS-EU, ENG93/42 Universal Oximetry System MODEL X-100, INT, PCS-EU, NONE93/42 Universal Oximetry System MODEL X-100, INT, PCS-UK, NONE93/42 Universal Oximetry System MODEL X-100, INT, PCS-UK, NONE, ENG93/42 Universal Oximetry System MODEL X-100, INT, PCS-US, ENG93/42 Universal Oximetry System MODEL X-100, LONG, PCS-EU, NONE, ENG93/42 Universal Oximetry System MODEL X-100, LONG, PCS-UK, NONE, ENG93/42 Universal Oximetry System MODEL X-100, LONG, PCS-US, JAPAN, ENG93/42 Universal Oximetry System MODEL X-100, LONG, PCS-US, NONE, ENG93/42 Universal Oximetry System PKG ASSY, X-100SP-1/INT-10093/42 Universal Oximetry System PKG ASSY, X-100SP-2/INT-10093/42 Universal Oximetry System PKG ASSY, X-100SP-3/INT-10093/42 Universal Oximetry System PKG ASSY, X-100SP-4/INT-10093/42 Universal Oximetry System PKG ASSY, X-100SP-5/INT-10093/42 Universal Oximetry System PKG ASSY, X-100SP-6/INT-10093/42 Vital Signs Monitor Capnography/Pulse Oximeter MODEL LS1-9R, 8000AA-3, US93/42 Wireless Handheld Multi-Parameter System (H500) MODEL CO-PILOT93/42 Wrist-Worn Pulse Oximeter MODEL 3150 BLE, 8000AA-WO293/42 Wrist-Worn Pulse Oximeter MODEL 3150 BLE, 8000J-WO293/42 Wrist-Worn Pulse Oximeter MODEL 3150 BLE, 8000SL-WO293/42 Wrist-Worn Pulse Oximeter MODEL 3150 BLE, 8000SM-WO293/42 Wrist-Worn Pulse Oximeter MODEL 3150 BLE, 8000SS-WO293/42 Wrist-Worn Pulse Oximeter MODEL 3150 USB, 8000AA-WO293/42 Wrist-Worn Pulse Oximeter MODEL 3150 USB, 8000J-WO293/42 Wrist-Worn Pulse Oximeter MODEL 3150 USB, 8000SL-WO293/42 Wrist-Worn Pulse Oximeter MODEL 3150 USB, 8000SM-WO293/42 Wrist-Worn Pulse Oximeter MODEL 3150, WRIST-OX2, BLE93/42 Wrist-Worn Pulse Oximeter MODEL 3150, WRIST-OX2, BLE, PACK, NOX93/42 Wrist-Worn Pulse Oximeter MODEL 3150, WRIST-OX2, BLE, PHILIPS93/42 Wrist-Worn Pulse Oximeter MODEL 3150SC, WRIST-OX2 USB COMM CABLE, PHILIPS93/42 Wrist-Worn Pulse Oximeter MODEL 3150USB, 8000SS-WO293/42 WristOx2® Model 3150 MODEL 3150WB, PKG ASSY, 3150WB, WRISTBAND93/42 WristOx2® Model 3150 with Bluetooth® Low Energy Wrist-Worn Pulse Oximeter MODEL 3150, WRIST-OX2, BLE93/42	IIb 93/42	EUDAMED record Report an error

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