Instruments to support and monitor vital signsVital signs monitoring instrumentsGaseous exchange monitoring instruments

Pulse oximeters

EMDN code Z1203020408

58 manufacturers, 485 models including 481 on the market, 10 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 58

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

Manufacturer	Country	Registered models	Class	Contact
Nonin FDA EU representative : MPS Medical Product Service GmbH (Germany)	United States	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	regulatory@nonin.com EUDAMED record Report an error
Beijing Choice Electronic Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	FL31393/42 FL32393/42 Handheld Pulse Oximeter MD300M93/42 LTD80093/42 LTD80593/42 55 others M-50B93/42 M-50C93/42 M-50E93/42 MD300K293/42 MD300M93/42 MD300W62893/42 ME593/42 PM A1093/42 PM A1993/42 PO 4593/42 Pulse Oximeter MD300C1393/42 Pulse Oximeter MD300C1993/42 Pulse Oximeter MD300C293/42 Pulse Oximeter MD300C20393/42 Pulse Oximeter MD300C20893/42 Pulse Oximeter MD300C2193/42 Pulse Oximeter MD300C2293/42 Pulse Oximeter MD300C22893/42 Pulse Oximeter MD300C2393/42 Pulse Oximeter MD300C2693/42 Pulse Oximeter MD300C2993/42 Pulse Oximeter MD300C4193/42 Pulse Oximeter MD300C593/42 Pulse Oximeter MD300C5293/42 Pulse Oximeter MD300C5393/42 Pulse Oximeter MD300C5493/42 Pulse Oximeter MD300C5593/42 Pulse Oximeter MD300CI series, MD300CN1 series, MD300CN3 series, MD300C5 series, MD300C2 series, MD300C1 series, OX2003 refs Pulse Oximeter MD300CI21693/42 Pulse Oximeter MD300CI216R, MD300CI218R2 refs Pulse Oximeter MD300CI21893/42 Pulse Oximeter MD300CN13093/42 Pulse Oximeter MD300CN14093/42 Pulse Oximeter MD300CN15093/42 Pulse Oximeter MD300CN16093/42 Pulse Oximeter MD300CN31093/42 Pulse Oximeter MD300CN33093/42 Pulse Oximeter MD300CN330R, MD300CN350R, MD300CN356R3 refs Pulse Oximeter MD300CN34093/42 Pulse Oximeter MD300CN35093/42 Pulse Oximeter MD300CN35693/42 Pulse Oximeter MD300CN36093/42 Pulse Oximeter MD300K293/42 Pulse Oximeter MD300K2N Pulse Oximeter MD300MNR Pulse Oximeter MD300W series2 refs Pulse Oximeter OX20093/42 Pulse Oximeter OXY30093/42 Pulse Oximeter P300 Intelli IT(HPO-300T)93/42 PX-100-EU93/42 PX-101-EEU93/42 PX-101-EU93/42 TS 370PO93/42 TS 380PO93/42 Wrist Pulse Oximeter MD300W62893/42	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Masimo FDA EU representative : MDSS GmbH (Germany)	United States	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	Website customerorders@masimo.com EUDAMED record Report an error
Contecmed FDA EU representative : Prolinx GmbH (Germany)	China	Pulse Oximeter ANP10093/42 Pulse Oximeter CMS50-Pro93/42 Pulse Oximeter CMS50D+93/42 Pulse Oximeter CMS50D-BT93/42 Pulse Oximeter CMS50D193/42 30 others Pulse Oximeter CMS50D293/42 Pulse Oximeter CMS50D2-193/42 Pulse Oximeter CMS50DL, CMS50D2 refs Pulse Oximeter CMS50DL193/42 Pulse Oximeter CMS50DL293/42 Pulse Oximeter CMS50E93/42 Pulse Oximeter CMS50F93/42 Pulse Oximeter CMS50I93/42 Pulse Oximeter CMS50M93/42 Pulse Oximeter CMS50N93/42 Pulse Oximeter CMS50Q193/42 Pulse Oximeter CMS50QA93/42 Pulse Oximeter CMS50QB93/42 Pulse Oximeter CMS60C93/42 Pulse Oximeter CMS60D93/42 Pulse Oximeter CMS60D193/42 Pulse Oximeter CMS70A93/42 Pulse Oximeter NX-8740-67593/42 Pulse Oximeter PO-10093/42 Pulse Oximeter PO-20093/42 Pulse Oximeter PO-200A Solo93/42 Pulse Oximeter PO-200Solo93/42 Pulse Oximeter PO-23093/42 Pulse Oximeter PO-25093/42 Pulse Oximeter PO-30093/42 Pulse Oximeter PO-40093/42 Pulse Oximeter PO-650A93/42 Pulse Oximeter PO-650B93/42 Pulse Oximeter PO-90093/42 Pulse Oximeter SAT-50093/42	IIa, IIb MDR, 93/42	Website pms.qms@contecmed.com EUDAMED record Report an error
Konsung FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	konsung SONOSAT-K01R, SONOSAT-K02R, SONOSAT-K01SR, SONOSAT-K02SR, SONOSAT-K01W, SONOSAT-K02W, SONOSAT-K01SW, SONOSAT-K02SW, SONOSAT-K01T, SONOSAT-K02T, SONOSAT-K01LT, SONOSAT-K02LT, SONOSAT-K01P, SONOSAT-K02P, SONOSAT-K01LP, SONOSAT-K02LP SONOSAT-F01LP93/42 SONOSAT-F01LT93/42 SONOSAT-F01LW93/42 SONOSAT-F01P93/42 13 others SONOSAT-F01W93/42 SONOSAT-F02LP93/42 SONOSAT-F02LT93/42 SONOSAT-F02LW93/42 SONOSAT-F02P93/42 SONOSAT-F02T93/42 SONOSAT-F02W93/42 SONOSAT-W01LP93/42 SONOSAT-W01LT93/42 SONOSAT-W01LW93/42 SONOSAT-W01P93/42 SONOSAT-W01T93/42 SONOSAT-W01W93/42	IIa MDR, 93/42	EUDAMED record Report an error
Shanghai Berry Electronic Tech FDA EU representative : Prolinx GmbH (Germany)	China	Pulse Oximeter BM100093/42 Pulse Oximeter BM1000A93/42 Pulse Oximeter BM1000B93/42 Pulse Oximeter BM1000C93/42 Pulse Oximeter BM1000D93/42 9 others Pulse Oximeter BM1000E93/42 Pulse Oximeter BM200093/42 Pulse Oximeter BM2000A93/42 Pulse Oximeter BM2000B93/42 Pulse Oximeter BM2000C93/42 Pulse Oximeter BM2000D93/42 Pulse Oximeter BM2000E93/42 Pulse Oximeter BM2000F93/42 Pulse Oximeter OSAsense S1893/42	IIa 93/42	Radepartment@shberrymed.com EUDAMED record Report an error
Viatomtech FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Babytone PO5, PO5-1, PO5-2, PO5-33 refs LEPU MEDICAL PF-10AW、PF- 10AW1、PF-10A、PF-10A1、PF-10BW、PF- 10BW1、PF-10B、PF-10B13 refs LEPU MEDICAL PO2, PO4，PO2A，PO2B，PO2S，PO2C，PO2C-A，PO2C-S， PO4S，PO4C，PO4C-S3 refs PF-10AW93/42 PO1B93/42 7 others PO493/42 PO693/42 Viatom Oxiband、Oxiduck、Oximax、Oxiduckm、Oxiultra、Oxiultra01、Oxiducku、Oxiduckp3 refs Viatom PO6、PO6A、 PO1、 PO1B2 refs Viatom VTM01、VTM01A、VTM01B2 refs VTM01A93/42 Wellue PO6B、PO6C2 refs	IIa MDR, 93/42	EUDAMED record Report an error
Draeger FDA EU representative : Drägerwerk AG & Co. KGaA (Germany)	United States	INFINITY MASIMO SP02 POD USB 05073993/42 INFINITY MASIMO SPO2 POD X8 05074693/42 Infinity Nellcor SpO2 Pod X8 04930693/42 POD MULTIMED 12-Lead + SpO2 00852593/42 SPO2 DRÄGER ERN. SCHAUM, 24STK 00535793/42 6 others SPO2 DRÄGER ERW. VINYL, 24STK 00531993/42 SPO2 DRÄGER NERO BAND, 24 STK 00534093/42 SPO2 DRÄGER PÄD. SCHAUM, 24STK 00536493/42 SPO2 DRÄGER PÄD. VINYL, 24STK 00532693/42 SPO2 DRÄGER SÄUGL. BAND, 24STK 00533393/42 SPO2-Sensor, Dräger, Mehrweg 00701693/42	IIb 93/42	Website EUDAMED record Report an error
Covidien FDA EU representative : Medtronic B.V. (Netherlands)	United States	10076644 NELLCOR SPO2 MODULE W CABLEX193/42 DS100A DURASENSOR ADT DIGIT X193/42 INVOS PM7100 RE-USABLE SENSOR CABLE3 refs Nellcor NS Disposable Sensors Nellcor NS Reusable Sensor Accessories3 refs 5 others Nellcor NS Snsr Acc for Reus/Dis. Snsrs3 refs OxySoft Neonatal-Adult SpO2 sensor3 refs PMC10GE120N;PMC10GE360N2 refs PMC10N-SF PMC10NCH-GE	I, IIb MDR, 93/42	EUDAMED record Report an error
Comdek EU representative : MedNet EC-REP IIb GmbH (Germany)	Taiwan	e-Angel Pulse Oximater MD-651P93/42 e-Angel Pulse Oximater MD-653P93/42 i-Oximeter MD-620P93/42 Portable Palme Pulse Oximeter MD-680P93/42 Portable Pulse Oximeter MD-600P93/42 6 others Portable Pulse Oximeter MD-610P93/42 Portable Pulse Oximeter MD-630P93/42 Portable Pulse Oximeter MD-670P93/42 Traveler Oximeter MD-650P93/42 Portable Pulse Oximeter MD-655P93/42 (no longer marketed) Traveler Oximeter MD-652P93/42 (no longer marketed)	IIb 93/42	info@comdek.com EUDAMED record Report an error
Shenzhen Creative Industry FDA EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands) and 1 other	China	AP-10、PC-68B2 refs Fingertip Oximeter PC-60A93/42 Novama Expert® Ręczny Pulsoksymetr HPOXY, model PC-66A, wariant S1 SP-20、PC-66A2 refs PC-60B1、POD-3、PC-60F、PC-60FW3 refs PC-60B、POD-2、POD-2W3 refs 4 others PC-60D2 PC-60D32 refs PC-60E、PC-60N、PC-60NW3 refs PC-66B、PC-66B1、PC-66B23 refs POD-1、POD-1W2 refs	IIa MDR, 93/42	Website info@creative-sz.com EUDAMED record Report an error
Rossmax FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Taiwan	RESQ-METER SB20093/42 Rossmax SA30093/42 Rossmax SA31093/42 Rossmax SB10093/42 Rossmax SB20093/42 3 others Rossmax SB21093/42 Rossmax SB22093/42 Rossmax SD10093/42	IIb 93/42	Website info@rossmax.com EUDAMED record Report an error
Shenzhen Everbest Machinery lndustry EU representative : Lotus NL B.V. (Netherlands)	China	Pulse Oximeter OX-68 Pulse Oximeter OX-68H Pulse Oximeter OX-97 Pulse Oximeter OX-97H Pulse Oximeter OX-98 3 others Pulse Oximeter OX-98B Pulse Oximeter OX-99 Pulse Oximeter OX-99H	IIa MDR	EUDAMED record Report an error
Shenzhen Yimi Life Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) and 1 other	China	Dr. Max Pulse Oximeter YM10193/42 Fingertip Pulse Oximeter YM101, YM102, YM103, YM104, YM201, YM202, YM301, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM401, YM402, YM403, YM501, YM502, YM503, YM504, YM601, YM602, YM6033 refs Pulse Oximeter YH01,YH022 refs Pulse Oximeter YM10193/42 Pulse Oximeter YM10293/42 2 others Pulse Oximeter YM10393/42 Pulse Oximeter YM20193/42	IIa MDR, 93/42	EUDAMED record Report an error
Xuzhou Yongkang Electronic Science Technology FDA EU representative : Prolinx GmbH (Germany)	China	BIOPAX3 refs Endostall6 refs K193/42 YK-820A93/42 YK-820B93/42 2 others YK-84B93/42 YK-84C93/42	IIa MDR, 93/42	Website EUDAMED record Report an error
Medlab	Germany	110 h93/42 P-OX100L3 refs93/42 PEARL100L5 refs93/42 PEARL56 refs93/42 PEARL83 refs93/42 1 other VITROmap3 refs93/42	IIb 93/42	Website sales@medlab.eu EUDAMED record Report an error
Beurer	Germany	PO 13 PO 302 refs PO 35 PO 4593/42 PO 60	IIa MDR, 93/42	info@beurer.de EUDAMED record Report an error
Shenzhen Witleaf Medical Electronics FDA EU representative : Zug Medical Systems (France)	China	Fingertip Pulse Oximeter2 refs Fingertip Pulse Oximeter WIT-S20093/42 Fingertip Pulse Oximeter WIT-S40093/42 Handheld Pulse Oximeter WIT-S100 Handheld Pulse Oximeter WIT-S30093/42	IIa MDR, 93/42	Website EUDAMED record Report an error
Fitfaith FDA EU representative : Lotus NL B.V. (Netherlands)	China	F380 Finger Oximeter F38093/42 Finger Pulse Oximeter M130/M160/M1703 refs PULSE OXIMETER M100 M110 M120 M130 M150 M160 M17093/42	IIa MDR, 93/42	EUDAMED record Report an error
Hunan Accurate Bio-Medical Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	FINGERTIP OXIMETER FS20A3 refs Pulse Oximeter HS10A3 refs Pulse Oximeter WS20A SPO2 Sensors A403S-013 refs	IIa, IIb MDR	regulation@accbiomed.com EUDAMED record Report an error
Meditech FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	Pulse Oximeter Fos2 Plus93/42 Pulse Oximeter Oxy93/42 Pulse Oximeter Oxyo Pro93/42 Pulse Oximeter OxyT93/42	IIa 93/42	Website sales@meditech.cn EUDAMED record Report an error
Sino-Hero(Shenzhen) Bio-Medical Electronics EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Pulse Oximeter S693/42 Pulse Oximeter S893/42 Pulse Oximeter S993/42	IIa, IIb 93/42	EUDAMED record Report an error
Acare Technology FDA EU representative : Surpass Biomedical Europe B.V. (Netherlands)	Taiwan	Pulse Oximeter AH-MX93/42 Pulse Oximeter AH-TA93/42	IIb 93/42	info@acarecorp.com EUDAMED record Report an error
Acurio EU representative : MedNet EC-REP GmbH (Germany)	China	FINGERTIP PULSE OXIMETER AS-30193/42 PULSE OXIMETERS AS-302-L93/42	IIb 93/42	EUDAMED record Report an error
Andon Health FDA EU representative : iHealthLabs Europe SAS (France)	China	PC-PO 3104(PO6)3 refs PO6L93/42	IIa MDR, 93/42	EUDAMED record Report an error
Edan FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Finger Oximeter H103 refs Pulse Oximeter H100B2 refs	IIa, IIb MDR	EUDAMED record Report an error
Envisen FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Pulse Oximeter93/42 Pulse Oximeter HandyOxi50093/42	IIb 93/42	EUDAMED record Report an error
Guangdong Biolight Meditech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Fingertip Pulse Oximeter M70, M70A, M70B, M70C, M70D3 refs Pulse Oximeter M800	IIa MDR	Website EUDAMED record Report an error
JOYTECH Healthcare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Fingertip Pulse Oximeter3 refs Fingertip Pulse Oximeter XM-101	IIa MDR	info@sejoy.com EUDAMED record Report an error
medical ECONET	Germany	Palmcare PRO93/42 Palmcare PRO (Li-Ion)93/42	IIb 93/42	Website info@medical-econet.com EUDAMED record Report an error
Shenzhen Aeon Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Pulse Oximeter A300, A310, A320, A330, A340, A310L, A340L3 refs Pulse Oximeter A31093/42	IIa MDR, 93/42	Website EUDAMED record Report an error
Shenzhen Bsx Technology Electronics FDA EU representative : MedNet EC-REP GmbH (Germany)	China	BSX253,BSX233,BSX251,BSX255B,BSX238B,BSX231 BSX32293/42	IIa MDR, 93/42	EUDAMED record Report an error
Utech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Fingertip Pulse Oximeter iO293/42 Pulse Oximeter UT100、UPM50、UPM603 refs	IIa, IIb MDR, 93/42	Website EUDAMED record Report an error
Delbio EU representative : Delta Electronics (Netherlands) B.V. (Netherlands)	Taiwan	SPENGLER DB1293/42 Aposán DB1293/42 (no longer marketed) DB11093/42 (no longer marketed)	IIa 93/42	Website EUDAMED record Report an error
Aojmedical FDA EU representative : Share info GmbH (Germany)	China	PULSE OXIMETER AOJ-70A\AOJ-70B\AOJ-70C\AOJ-70D\AOJ-70E\OXI-70B\OXI-70D\OXI-70E\OXI-70F\OXI-70G\OXI-70H3 refs	IIa MDR	regulation@aojmedical.com EUDAMED record Report an error
AViTA FDA EU representative : MDSS GmbH (Germany)	Taiwan	Pulse oximeter SP643 refs	IIa MDR	Website Info@avita.com.tw EUDAMED record Report an error
Biocare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Fingertip Pulse Oximeter BP-10M93/42	IIb 93/42	regulation@biocare.com.cn EUDAMED record Report an error
Bistos FDA EU representative : Obelis s.a. (Belgium)	South Korea	Gateway BT-71093/42	IIb 93/42	Website EUDAMED record Report an error
Cofoe FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	Pulse Oximeter OHT60, OHT80, OXH78, OXH883 refs	IIa MDR	Website EUDAMED record Report an error
Genial FDA EU representative : MedPath GmbH (Germany)	China	Finger Clip Pulse Oximeter GX103 refs	IIa MDR	admin@genial.cn EUDAMED record Report an error
Hans Dinslage	Germany	SPO 253 refs	IIa MDR	service@sanitas-online.de EUDAMED record Report an error
Henry Schein FDA EU representative : Henry Schein Services GmbH (Germany)	United States	Henry Schein TF-04893/42	IIa 93/42	Website EUDAMED record Report an error
Honeywell FDA	Germany	OxiPen (ohne Sensor)	IIb MDR	Website EUDAMED record Report an error
Lintemed FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Fingertip Pulse Oximeter3 refs	IIa MDR	Website EUDAMED record Report an error
MESI, razvoj medicinskih naprav, d.o.o	Slovenia	MESI mTABLET SPO2 diagnostic system MTABSYSSPO293/42	IIa 93/42	Website info@mesimedical.com EUDAMED record Report an error
MIR - Medical International Research FDA	Italy	Spirodoc MIR040	IIa MDR	Website EUDAMED record Report an error
Nihon Kohden FDA EU representative : NIHON KOHDEN EUROPE GmbH (Germany)	Japan	Pulse Oximeter　OLV-4201	IIb MDR	Website information@db.nkc.co.jp EUDAMED record Report an error
Parsianmedical EU representative : Glomin GmbH (Germany)	Iran	Parsian Medical ABADIS711	IIb MDR	Website info@parsianmedical.com EUDAMED record Report an error
Shanxi Jerry Medical Instrument EU representative : Wellkang Ltd (Northern Ireland)	China	Fingertip Pulse Oximeter3 refs	IIa MDR	exportsales@sxjerrymed.com EUDAMED record Report an error
Shenzhen IMDK Medical Technology FDA EU representative : MedNet EC-REP GmbH (Germany)	China	IMDK Pulse Oximeter C101H1, C101A2, PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT3 refs	IIa MDR	service@imdker.com EUDAMED record Report an error
Shenzhen Jumper Medical Equipment FDA EU representative : MedPath GmbH (Germany)	China	CHDE&Microlife3 refs	IIa MDR	EUDAMED record Report an error
Shenzhen Med-link Electronics Tech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Pulse Oximeter AM80193/42	IIa 93/42	Website sales@med-linket.com EUDAMED record Report an error
Shenzhen Narig Bio-Medical Technology FDA EU representative : MedPath GmbH (Germany)	China	Kruidvat Pulse Oximeter FRO-200,FRO-201,FRO-202,FRO-203, FRO-204, FRO-100, FRO-101, FRO-102,FRO-103, FRO-1043 refs	IIa MDR	Website EUDAMED record Report an error
SLE EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	SLE6000 uSpo2 Cable (Masimo SET)93/42	IIb 93/42	EUDAMED record Report an error
Suntechmed FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	WK1002 refs	IIa MDR	Website EUDAMED record Report an error
Taidoc FDA EU representative : MedNet EC-REP GmbH (Germany)	Taiwan	FORA PO200 Fingertip Pulse Oximeter93/42	IIa 93/42	Website sales@taidoc.com EUDAMED record Report an error
Unimed FDA EU representative : Obelis s.a. (Belgium)	China	Reusable Adult Finger Clip SpO2 Sensor93/42	IIb 93/42	Website info@unimed.cn EUDAMED record Report an error
Yuyue FDA EU representative : Metrax GmbH (Germany)	China	YUWELL® Finger Pulse Oximeter YX102, YX105, YX106, YX110,YX301, YX306, YX3103 refs	IIa MDR	qa.yuwell@yuyue.com.cn 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.

Other manufacturers known in the United States (FDA) 58

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

Manufacturer	Country	Brands	FDA clearance
EINSTEIN ASSOCIATES LLC	–	Zacurate Innovo	registered
HEALTH CONNECTOR LLC	–	Acc U Rate Zacurate	registered
GURIN PRODUCTS LLC	United States	Santamedical	registered
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	–	CVS Health	registered
TRIWALKER SERVICES LLC	–	TrackAid	registered
Clinical Guard	–	Clinical Guard	registered
Drive Devilbiss Healthcare	United States	Medquip Carex Roscoe Medical Drive	registered
EASY HEALTHCARE CORPORATION	–	Easy@Home Fingertip Pulse Oximeter Easy@Home Pulse Oximeter	registered
Dms Laboratories	United States	HealthSmart	registered
FKA DISTRIBUTING CO., LLC	–	HOMEDICS	registered
Innovo Medical	–	Innovo	registered
SUNSET HEALTHCARE SOLUTIONS, INC.	United States	Fingertip Pulse Oximeter with 6-way Display Oximeters Sunset Fingertip Pulse Oximeter Oximeter	registered
WAL-MART STORES, INC.	–	ReliOn Equate	registered
Guangdong Long Yao Electronic Technology Co., Ltd.	China	iox eox	registered
MEDLINE INDUSTRIES, INC. Present in Europe in other categories	United States	Medline	registered
MHC MEDICAL PRODUCTS, LLC	–	Surelife Kroger	registered
Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd	China	AccuMed CONCORD	registered
TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC	–	Dr. Talbot's	registered
VERIDIAN HEALTHCARE LLC	–	Veridian SmartHeart	registered
VIVE HEALTH LLC Present in Europe in other categories	United States	VIVE	registered
WALGREEN CO.	–	Walgreens Well at Walgreens	registered
Amerisourcebergen Drug Corporation	–	Good Neighbor	registered
BEURER NORTH AMERICA, L.P.	–	CONTEC Beurer	registered
BOXOUT, LLC	–	BodyMed	registered
CMI HEALTH INC.	United States	OxyKnight CMI Health	registered
Changsha Brilliant Easesyn Technology Co.,Ltd.	China	Concord	registered
EMAY (HK) LIMITED	–	EMAY	registered
GOLDEN SMART HOME TECHNOLOGY CORP.	Taiwan	WowGoHealth Pulse Oximeter GSH601	registered
LEADTEK RESEARCH, INC.	Taiwan	Leadtek	registered
OXIMETER PLUS, INC.	–	Oximeter Plus	registered
Sevenground Trading B.V.	Netherlands	iProvèn	registered
iHealth Labs Inc.	United States	iHealth	registered
AMAZON.COM SERVICES LLC	–	Amazon Basic Care	registered
ByFlo LLC	–	ByFloProducts	registered
Caring Mill	–	Caring Mill	registered
Gpd Health LLC	–	GPD Health	registered
Inland Products, Inc.	–	ProHT	registered
Jiangxi Aicare Medical Technology Co., Ltd. Present in Europe in other categories	China	AILE fingertip pulse oximeter	registered
Joicom Corporation	United States	RENPHO Pulse Oximeter	registered
KAZ USA, INC. Present in Europe in other categories	United States	Braun	registered
KONQUEST GROUP INC	–	KONQUEST	registered
MEDICAL TEST SUPPLY	–	MTS	registered
Star Elite Inc	Canada	Sunbeam	registered
TREND POWER LIMITED	–	MOVE 78 Cold & Flu Kit	registered
Thermor Ltd	Canada	BIOS	registered
AMARIGO INC	United States	–	registered
Andon Medical Co., Ltd.	China	–	registered
Beijing Choice Electronic Technololgy Co., Ltd.	China	–	registered
GIANTSUN POWER ELECTRONICS (VIETNAM) CO., LTD	Vietnam	–	registered
Guangdong HealthTree Medical Technology Co., Ltd.	China	–	registered
Guangzhou Berrcom Medical Device Co., Ltd. Present in Europe in other categories	China	–	registered
Hian (Hong Kong) Co., Limited	Hong Kong SAR China	–	registered
Kaz USA, Inc., A Helen of Troy Company	United States	–	registered
LONGCHEER MEIKO ELECTRONICS VIETNAM COMPANY LIMITED	Vietnam	–	registered
LUXSHARE - ICT (NGHE AN ) LIMITED	Vietnam	–	registered
Shenzhen Changkun Technology Co., Ltd. Present in Europe in other categories	China	–	registered
Shenzhen Taikang Medical Equipment Co., Ltd.	China	–	registered
Shenzhen Yuezhongxing Technology Co., Ltd. Present in Europe in other categories	China	–	registered

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