Manufacturer

Philips

China, Finland, Germany, India, Netherlands, United StatesLegal entities : Invivo, a division of Philips Medical Systems, Philips Consumer Lifestyle B.V., Philips DS North America LLC

First countries of placing on the market declared in EUDAMED : Austria, Belgium, Bulgaria, Cyprus, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden

Public contracts won : France 191, Germany 80, Austria 44, Italy 29, Finland 21, Poland 13, Switzerland 12, Netherlands 7, Belgium 1, Ireland 1, Spain 1, Sweden 1

EU representative : Philips Medical Systems Nederland B.V. (Netherlands)

eudamed@philips.com

85 categories, 427 models including 374 on the market, 6 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
Multi-parameter monitors - other	Z1203020299	1-CHANNEL CHEMICAL THERMAL PAPER, GRAY3 refs 5 Lead ECG Trunk Cable, AAMI/IEC3 refs 5 lead set Disposable, Bedside, AAMI3 refs 5 Leadset, Grabber,Chest, AAMI,ICU3 refs 86524493/42 87 others Adult NBP Cuff3 refs Adult SpO2 Clip Reusable SpO2 Clips and Single use Grips3 refs Airway Adapter Set H - ET >4.0 mm93/42 CapnoLine H O2 Infant/Neonatal93/42 CapnoLine H O2 Pediatric93/42 CapnoLine H O2/Adult93/42 Chemical/Thermal Paper3 refs CO2 / O2 Nasal Cannula - Adult93/42 CO2 / O2 Nasal Cannula - Pediatric93/42 CO2 / O2 Oral-Nasal Cannula - Pediatric93/42 CO2 Nasal Cannula - Adult CO2/O2 Nasal Cannula93/42 CO2 Nasal Cannula - Pediatric CO2/O2 Nasal Cannula93/42 CO2 Oral-Nasal Cannula - Adult CO2/O2 Oral-Nasal Cannula93/42 CO2 Oral-Nasal Cannula - Pediatric CO2/O2 Oral-Nasal Cannula93/42 EarlyVue VS30 Vital Signs Monitor EASY CARE CUFF, 1 HOSE, ADULT (1)3 refs EFFICIA 3-LEAD GRABBER, AAMI3 refs Efficia BIS Module Efficia Cardiac Output Module Efficia CM103 refs Efficia dual IBP module Efficia Gas Module with O22 refs Efficia Microstream CO2 module Efficia CO2 Module Efficia Rack Esophageal/Rectal Temperature Probe 21076A93/42 Esophageal/Rectal Temperature Probe 21090A93/42 Esophageal/Rectal Temperature Probe M1837A93/42 Expression Information Portal (IP5) Expression IP5 Information Portal (REF 893/42 Expression MR400 MRI Patient Monitor Sys Flexible Module Server93/42 Flexible Module Server FMX-4 FlexTEMP II Sensor93/42 FlexTEMP System, Jacket93/42 Foley Catheter Temperature Probe3 refs93/42 IntelliVue Capnography Extension IntelliVue Dock IntelliVue FMS-493/42 IntelliVue Hemodynamic Extension IntelliVue Microstream Extension IntelliVue MX100 X3/MX1002 refs IntelliVue NMT Module93/42 Kit, Sample, Agents, 3160 Long Extra Wide ECG 2.0 Cable AAMI3 refs Measurement Rack 6000 MR200 MRI Patient Monitoring System93/42 Multiple Patch ECG Electrodes (25)3 refs Nasal Filterline O2 Adult93/42 Nasal Filterline O2 Pediatric93/42 Pediatric/Adult Ear Clip Sp02 Sensor SPO2 Sensors93/42 Philips Water Trap Printer Kit, Strip Chart, USB2 refs Quick Connect SpO2 Probe, MRI Reusable SpO2 Probes93/42 Remote Alarm Device93/42 Skin Surface Temperature Probe 21091A93/42 Smart CapnoLine Guard93/42 Smart CapnoLine Guard O293/42 Smart CapnoLine Guard O2 Long93/42 Smart CapnoLine H 02 Adult Long93/42 Smart CapnoLine H 02 Pediatric93/42 Smart CapnoLine H O2 Adult93/42 Smart CapnoLine H O2 Pediatric Long93/42 Smart CapnoLine O2 Long, Pediatric93/42 Smart CapnoLine O2 Plus Long, Adult93/42 SMART CAPNOLINE O2 plus, ADULT, intermed93/42 SMART CAPNOLINE O2, PEDIATRIC93/42 Smart CapnoLine Plus Long, Adult93/42 SMART CAPNOLINE plus, ADULT, intermed93/42 Solid Gel Tab Electrode, Resting ECG SpO2 Sensor Reusable SpO2 Probes Straight Sample Line93/42 Straight Sample Line H93/42 Temperature Parameter Module Thermal Printer Kit, USB Universal Gating Interface Wireless ECG 2.0 Module Wirelss Gating&Wirelss ECG/SpO2 Modules93/42 Wireless ECG 3.0 Module (Networks 1-5) Expression MR400 MRI Patient Monitor Sys93/42 Wireless ECG 3.0 Module (Networks 1-5) Wireless ECG/SpO2 Gen 3 Modules3 refs Wireless ECG 3.0 Module (Networks 6-10) Expression MR400 MRI Patient Monitor Sys93/42 Wireless SP02 Module (Gen 2) Wirelss Gating&Wirelss ECG/SpO2 Modules93/42 Wireless SpO2 3.0 Module (Networks 1-5) Expression MR400 MRI Patient Monitor Sys93/42 Wireless SpO2 3.0 Module (Networks 6-10) Expression MR400 MRI Patient Monitor Sys93/42 Wireless SPO2 Patient Module Wirelss Gating&Wirelss ECG/SpO2 Modules93/42 Wireless WECG Module Wirelss Gating&Wirelss ECG/SpO2 Modules93/42 Airway Adapter Set - ET >4.0 mm93/42 (no longer marketed) CO2 / O2 Oral-Nasal Cannula - Adult93/42 (no longer marketed) MR Patient Care Portal 5000 (866162)93/42 (no longer marketed) Skin Surface Temperature Probe93/42 (no longer marketed)	I, IIa, IIb MDR, 93/42	EUDAMED record Report an error
Vital signs monitoring instruments - hardware accessories	Z12030280	862112 CBL Cardiac Output Cable2 refs CBL SpO2 Extension Cable, 2m SPO2 Adapters and Cables3 refs Dual IBP Adapter FloTrac 31 others Flow Sensor Adult / Pediatric93/42 Flow Sensor Neonatal93/42 IntelliBridge EC10 Module93/42 IntelliBridge EC5 ID-Module93/42 IntelliVue BIS Module93/42 IntelliVue EEG Module93/42 IntelliVue MMX IntelliVue NMT Hand-Adapter IntelliVue NMT Patient Cable93/42 M1192A Reusable P-S-A Finger SpO2 Sensor SPO2 Sensors93/42 M1193A Reus Neo H-F SpO2 Sensor (1.5m) SPO2 Sensors93/42 M1194A Reus A-P Ear Clp SpO2 Sensr 1.5m SPO2 Sensors93/42 Mainstream Sensor CO2 Sensors93/42 Masimo CO2 Module93/42 Masimo O3 Module93/42 Reusable Adult SpO2 Sensor SPO2 Sensors2 refs93/42 Reusable SpO2 Sensor Adult SPO2 Sensors93/42 SedLine Module93/42 Sidestream CO2 Sensor CO2 Sensors93/42 Single-Patient use Adult Airway Adapter93/42 Single-Patient use Infant Airway Adapter93/42 SPO2 Reus Adult Clip Sensor M1196A SPO2 Sensors93/42 SPO2 Reus Adult Clip Sensor M1196T SPO2 Sensors93/42 SPO2 SPU Adhsve-free Wrap Sensor M1134A SPO2 Sensors93/42 SPO2 SPU Infant Wrap Sensor M1132A SPO2 Sensors93/42 SPO2 SPU Neo-Inf-Adlt Wrap Sensor M1133A SPO2 Sensors93/42 SPO2 SPU Ped-Adlt Clip Sensor M1131A SPO2 Sensors93/42 Temperature Parameter Module93/42 Thermal Array Recorder Module Intravascular Oxygen Saturation Module SO2 Module93/42 (no longer marketed) SO2 Optical Module93/42 (no longer marketed)	I, IIa, IIb MDR, 93/42	EUDAMED record Report an error
Transportable/portable multi-parameter patient monitors	Z1203020202	3 LEADS SET DISPOSABLE, BEDSIDE IEC RD3 refs Adt Nsl CO2 Line LTerm3 refs Adt Nsl CO2 Line w/O2 STerm93/42 Adt Nsl CO2 Line w/O2 STerm Lng93/42 Adt Orl/Nsl CO2 Line w/O2 Conn STerm93/42 29 others Adt Orl/Nsl CO2 Line w/O2 Conn STerm Lng93/42 Adt Orl/Nsl CO2 Line w/O2 LTerm93/42 Adt Orl/Nsl CO2 Line w/O2 LTerm Lng93/42 Adt Orl/Nsl CO2 Line w/O2 STerm93/42 Adt/Med BiteBlk CO2 Line w/O2 Conn STerm93/42 Adt/Med BiteBlk CO2 Line w/O2 STerm93/42 Adt/Med BiteBlk CO2 Line w/O2 STerm Lng93/42 ADULT FOAM ECG ELECTRODE, DISPOSABLE3 refs ADULT NIBP AIR HOSE 3.0M2 refs CBL ECG 3 LEAD GRABBER, IEC + SPO2, TELE Reusable Leadsets/ECG leads/SPO2 Cables3 refs CBL ECG 5 LEAD GRABBER IEC+SPO2 SPU TELE IntelliVue MX40 Single-Patient-Use Cable93/42 CBL ECG 5lead Grabber,AAMI+SpO2,SPU,Tele IntelliVue MX40 Single-Patient-Use Cable93/42 COMFORT CARE CUFF, ADULT3 refs EFFICIA 3-LEAD GRABBER, AAMI3 refs INFANT SINGLE-PATIENT CUFF SIZE #53 refs Nasal Alar SpO2 Sensor FAST Only, 20/CS Alar Nasal SpO2 Sensors93/42 Nasal Alar SpO2 Sensor MLT CPTL, 24/CS Alar Nasal SpO2 Sensors93/42 Neo/Inf Nsl CO2 Line w/O2 LTerm93/42 NEONATAL NIBP AIR HOSE 1.5M2 refs NEONATAL/PEDIATRIC SNAP ELECTRODE,SQUARE3 refs Pedi Nsl CO2 Line w/O2 LTerm93/42 Pedi Nsl CO2 Line w/O2 STerm93/42 Pedi Orl/Nsl CO2 Line w/O2 LTerm93/42 Pedi Orl/Nsl CO2 Line w/O2 LTerm Lng93/42 Pedi Orl/Nsl CO2 Line w/O2 STerm93/42 Pedi Orl/Nsl CO2 Line w/O2 STerm Lng93/42 Telemetry Monitor 5500 Adt Nsl CO2 Line w/O2 LTerm93/42 (no longer marketed) Adt Orl/Nsl CO2 Line w/O2 STerm Lng93/42 (no longer marketed)	I, IIa, IIb MDR, 93/42	EUDAMED record Report an error
Digital angiography systems - medical device software	Z11030192	3D Roadmap 3D-RA AneurysmFlow Dynamic Coronary Roadmap EmboGuide 10 others EP navigator - 5 HeartNavigator -3 MR-CT Roadmap - 1 SmartCT StentBoost - 4 StentBoost Live UniGuide R1 VesselNavigator - 1 XperCT Dual - 3 XperGuide - 1	IIb MDR	EUDAMED record Report an error
Multi-parameter patient bedside monitors	Z1203020201	989803192931 SureSigns VS4 NBP, SPO2_Accessories93/42 Avalon CL Fetal & Maternal Patch G-Series patient monitor, Model is G30E2 refs IntelliVue Active Display AD75 AD75/AD85 Active Displays2 refs IntelliVue MP593/42 11 others IntelliVue Patient Monitor MP5SC93/42 IntelliVue Patient Monitor MX400 MX400-5503 refs IntelliVue Patient Monitor MX700 MX700/80093/42 IntelliVue Patient Monitor MX750 MX750/8502 refs IntelliVue Patient Monitor MX800 MX700/80093/42 IntelliVue XDS Software Patient Monitor 6100 Patient Monitor 6000 Series3 refs E/R Temp Probe 10 FR Reuse Autoclavable93/42 (no longer marketed) E/R Temp Probe 12 FR Reuse Autoclavable93/42 (no longer marketed) Esophageal/Rectal Temperature Probe93/42 (no longer marketed) Skin Temp Probe Reusable Autoclavable93/42 (no longer marketed)	I, IIa, IIb MDR, 93/42	EUDAMED record Report an error
Defibrillators - hardware accessories	Z12030580	DFM100 Lithium Ion Battery Efficia external Paddles93/42 External Paddles Water Resistant93/42 Extra Lrg Switched Int Pdls93/42 FR3 FAA Compliant Battery3 refs 14 others Intrepid New Cell Lithium Ion Battery Lrg Switched Int Pdls93/42 MDS90-18-PHI Medium Switched Int Pdls93/42 Pads Adapter Cable Small Switched Int Pdls93/42 AC Power Module93/42 (no longer marketed) FR2 Primary Battery93/42 (no longer marketed) FR2 Rechargeable Battery93/42 (no longer marketed) Intrepid Lithium Ion Battery (no longer marketed) MRx Lithium Ion Battery Module93/42 (no longer marketed) Rect. Pdl Electrodes Pepl M3535A-Gray93/42 (no longer marketed) TSO C-142 Primary Battery93/42 (no longer marketed) XL+ Lithium Battery Module93/42 (no longer marketed)	I, IIb MDR, 93/42	EUDAMED record Report an error
Cardiotocographic telemetry instruments - other	Z1208010499	Avalon Cableless ECG/IUP Transducer93/42 Avalon Cableless Toco+ MP Transducer93/42 Avalon Cableless US Transducer93/42 Avalon CL Basestation93/42 Avalon CL Fetal & Maternal Pod93/42 6 others Avalon ECG/IUP Transducer93/42 Avalon Toco MP Transducer2 refs93/42 Avalon Toco+ Transducer93/42 Avalon Ultrasound Transducer93/42 MECG Adapter Cable Remote Event Marker	I, IIb MDR, 93/42	EUDAMED record Report an error
Various radiodiagnostic and interventional instruments - hardware accessories	Z11039080	Adjustable Straps3 refs Anti-scatter Grid (36/12/100)3 refs Console Trolley3 refs FootRest 8003 refs Infusion Bottle Holder3 refs 4 others Mobile Detector Holder3 refs Monitor CS for 1 Monitor (BNC)3 refs Patient Support3 refs Remote Control Holder2 refs	I, IIb MDR	EUDAMED record Report an error
X-ray tube assembly	Z11039012	CT XS Tube2 refs CT30003 refs CT80003 refs CTR1720 CTR17xx Family3 refs CTR2140CENM CTR2xxx Family3 refs 10 others DA 1094 DU 6943 refs DA200P40 DA200 Family3 refs MRC 200 0407 ROT-GS 10043 refs DU 1750 DA 9093/42 (no longer marketed) DU 2550 DA 90 HS93/42 (no longer marketed) DU 33100 DA 90 HS93/42 (no longer marketed) MRM 0410 ROT-GS 250293/42 (no longer marketed) SRM 0612 ROT 50093/42 (no longer marketed) SRM 0612 ROT 50493/42 (no longer marketed) SRO 33100 ROT 35193/42 (no longer marketed)	IIb MDR, 93/42	EUDAMED record Report an error
Foetal monitors	Z12080101	ATTACHMENT ELECTRODE AVALON CL BELT CLIP4 refs Avalon FM20 Fetal Monitor FM20-5093/42 Avalon FM30 Fetal Monitor FM20-5093/42 Avalon FM40 Fetal Monitor FM20-5093/42 3 others Avalon FM50 Fetal Monitor FM20-5093/42 DECG REUSABLE LEGPLATE ADAPTER PHILIPS FETAL SPIRAL ELECTRODE93/42	I, IIa, IIb MDR, 93/42	EUDAMED record Report an error
Multi-parameter monitors - consumables	Z1203020285	Adult NBP Cuff3 refs ADULT NIBP AIR HOSE 3.0M4 refs COMFORT CARE CUFF, ADULT XL3 refs EASY CARE CUFF, 1 HOSE, ADULT (1)3 refs INFANT SINGLE-PATIENT CUFF SIZE #53 refs 2 others NEONATAL NIBP AIR HOSE 1.5M4 refs Temperature Sensor Jacket2 refs	I, IIa MDR	EUDAMED record Report an error
Various digital bioimaging management instruments - software accessories	Z11069082	Advanced Visualization Workspace2 refs AV Cardiovascular Suite AV Viewer CT ASPECT Scoring2 refs IntelliSpace Portal93/42 2 others NM Suite2 refs Radiology Operations Command Center Console	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Defibrillators - consumables	Z12030585	3-Wire Lead Set and Plug Snap IEC3 refs CPR Meter Patient Adhesive Fast Response Kit FR3 Infant Child Key2 refs Heartstart Infant Child Smart Pads Cart. 2 others Smart Pads III3 refs HeartStart Pediatric Pads FR293/42 (no longer marketed)	I, IIb MDR, 93/42	EUDAMED record Report an error
Stationary angiography systems for angiographic and cardiologic studies	Z11030102	Arm support board3 refs Azurion 3 M124 refs Azurion 3 M1593/42 Azurion 7 M2093/42 Cerebral Filter2 refs 1 other Viewpad Vascular3 refs	I, IIb MDR, 93/42	EUDAMED record Report an error
Mobile radioscopic units	Z11039017	Zenition 10 Zenition 30 Zenition 50 Zenition 70 Zenition 90 4 others BV Endura (no longer marketed) BV Pulsera93/42 (no longer marketed) BV Vectra93/42 (no longer marketed) Veradius Unity93/42 (no longer marketed)	IIb MDR, 93/42	EUDAMED record Report an error
Picture archiving and communication systems	Z110603	IntelliSpace Cardiovascular 5 Philips FetView QLAB 13.03 refs TOMTEC-ARENA2 refs Vue PACS93/42 2 others IntelliSpace Clinical Applications93/42 (no longer marketed) IntelliSpace Radiology93/42 (no longer marketed)	I, IIa MDR, 93/42	EUDAMED record Report an error
Computed tomographs - not exceeding 2 layers	Z11030601	Ingenuity CT3 refs Spectral CT3 refs Spectral CT on Rails Spectral CT Verida Spectral CT Verida RT	IIb MDR	EUDAMED record Report an error
Electrocardiographs - hardware accessories	Z12050380	12L Leadset, 3mm needle AAMI Wireless PIM leadwires, 3mm AAMI/4mm IEC2 refs Chest Lead Set, AAMI/IEC TC 10, TC20, TC30, TC50, TC70 lead sets3 refs Class B USB Patient Data Cable Electrode, limb clamp Icon/C400 4/bx PW TC20 Long 10-Lead Patient Cable IEC3 refs	I MDR	EUDAMED record Report an error
High voltage X-ray generators	Z11039011	Certeray iX2 refs CG500 Product family Base model3 refs CT XS Generator Velara CVFD3 refs XS-100 Generator3 refs	IIb MDR	EUDAMED record Report an error
Multi-parameter monitors - hardware accessories	Z1203020280	CBL Reusable EEG Miniclip Leadset3 refs CBL Reusable EEG Pedi Cup Electrodes2 refs ECG 5 Lead Grabber IEC + SpO2, SPU, Tele2 refs ECG 5 lead Grabber, AAMI, Tele Lead sets w/wo SpO2 adapter and Cables3 refs EEG CBL 4CH Trunk Cable, 2.7m2 refs	I, IIb MDR	EUDAMED record Report an error
Multidisciplinary ultrasound scanners (internal and cardiology, etc.)	Z11040104	Affiniti 30 Diagnostic Ultrasound System3 refs EPIQ 5 Diagnostic Ultrasound System3 refs Lumify Diagnostic Ultrasound System3 refs Ultrasound System 5300 5000 Compact Series Ultrasound Systems3 refs	IIa MDR	EUDAMED record Report an error
General purpose electrocardiographs	Z12050301	Cardiac Workstation 5000/70002 refs PageWriter TC10 Cardiograph PageWriter TC35 Cardiograph PageWriter TC20 Cardiograph PageWriter TC30 Cardiograph93/42 (no longer marketed) PageWriter TC30 Cardiograph93/42 (no longer marketed) 2 others PageWriter TC50 Cardiograph PageWriter TC30 Cardiograph93/42 (no longer marketed) PageWriter TC70 Cardiograph PageWriter TC30 Cardiograph93/42 (no longer marketed)	IIa MDR, 93/42	EUDAMED record Report an error
Computed tomographs - 64 layers or more but less than 128 layers	Z11030605	CT Areta RT3 refs CT Scanner System (Philips CT 3500) IQon Spectral CT	IIb MDR	EUDAMED record Report an error
Digital angiography systems - software accessories	Z11030182	EchoNavigator93/42 EchoNavigator R4 HeartNavigator93/42	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Magnetic resonance (mr) systems - hardware accessories - other	Z1105018099	Acoustic Hood3 refs Flextrak OR Ingenia 1.5T2 refs MR-RT CouchTop3 refs	I MDR	EUDAMED record Report an error
Multifunctional systems for direct digital radiology	Z11031101	DigitalDiagnost C50 DuraDiagnost DuraDiagnost F30	IIb MDR	EUDAMED record Report an error
Fluoroscopy devices	Z11039009	CombiDiagnost R90 Rel 1.1 ProxiDiagnost N90 1.1 CombiDiagnost R9093/42 (no longer marketed) ProxiDiagnost N9093/42 (no longer marketed)	IIb MDR, 93/42	EUDAMED record Report an error
Mobile radiographic units	Z11039016	MobileDiagnost wDR R2.2 (for RoW)93/42 Radiography 7000 M MobileDiagnost wDR R2.1 (for RoW)93/42 (no longer marketed)	IIb MDR, 93/42	EUDAMED record Report an error
Various radiodiagnostic and interventional instruments - consumables	Z11039085	AltaTrack 3D Hub2 refs LumiGuide Docking Top AltaTrack Docking Top93/42 (no longer marketed)	I MDR, 93/42	EUDAMED record Report an error
Various radiodiagnostic and interventional instruments - other	Z11039099	DigitalDiagnost 4 Chest / Emergency3 refs LumiGuide Equipment3 refs AltaTrack Equipment2 refs (no longer marketed)	I, IIb MDR	EUDAMED record Report an error
Central information computing systems	Z12030201	Care Assist Android2 refs Patient Information Center iX	IIb MDR, 93/42	EUDAMED record Report an error
Closed magnet MRI scanners with magnetic field less than or equal to 2t	Z11050104	BlueSeal QE3 refs Marlin 1.5T3 refs	IIb MDR	EUDAMED record Report an error
Computed tomographs - 16 layers or more but less than 64 layers	Z11030603	Brilliance Big Bore System Upgrade2 refs CT Scanner System (MX 16-slice)	IIb MDR	EUDAMED record Report an error
Defibrillators - other	Z12030599	Efficia DFM100 Defibrillator/Monitor93/42 HeartStart Intrepid93/42	IIb 93/42	EUDAMED record Report an error
Digital laboratory microscopes	W0202050304	Pathology Scanner SG300i 1.x - IVD2 refs Philips IntelliSite Pathology Solution 5.x - IVDR3 refs	A IVDR	EUDAMED record Report an error
Electrocardiograph telemetry system transmitters	Z12050803	MX40 - 2.4 MX40 Patient Wearable Monitor93/42 MX40 - WLAN MX40 Patient Wearable Monitor93/42	IIb 93/42	EUDAMED record Report an error
Holter system instruments for cardiovascular parameters - hardware accessories	Z12050480	DigiTrak XT Patient Cable Long3 refs DigiTrak XT Patient Cable Medium2 refs	I MDR	EUDAMED record Report an error
Instruments for cardiological polygraphy - software accessories	Z12050782	Philips Hemodynamic Application Philips Interventional Hemodynamic System2 refs	IIb MDR	EUDAMED record Report an error
Magnetic resonance (mr) radiofrequency surface coils	Z1105018001	MR coils (dS TorsoCardiac 1.5T/dS MSK S 1.5T/dS MSK M 1.5T)3 refs MR coils (Smart Fit Shoulder 1.5T/Smart Fit TorsoCardiac 1.5T)2 refs	IIa MDR	EUDAMED record Report an error
Prenatal diagnostic instruments - medical device software	Z12080192	IntelliSpace Perinatal K Large Arch.93/42 IntelliSpace Perinatal K Small Arch.93/42	IIa 93/42	EUDAMED record Report an error
Semi-automatic defibrillators	Z12030501	Heartstart FRx93/42 HeartStart HS1 Defibrillator and Accs.93/42	IIb 93/42	EUDAMED record Report an error
Surgical navigation instruments - hardware accessories	Z12011480	20004 PercuNav Ultrasound Tracker3 refs Planar Field Generator with Stand2 refs	I MDR	EUDAMED record Report an error
Ultrasound scanners - hardware accessories - other	Z1104018099	Deluxe Compact Cart, Chinese3 refs Lumify Micro B Transducer Cable3 refs	I MDR	EUDAMED record Report an error
Vital signs monitoring instruments - medical device software	Z12030292	Intellispace CC & Anesthesia IntelliVue GuardianSoftware	IIb MDR	EUDAMED record Report an error
Bioimaging processors	Z11069001	Cardiac Output Parameter Module93/42 IntelliBridge EC40/80 (no longer marketed) IntelliSpace Consultative Critical Care93/42 (no longer marketed)	I, IIb MDR, 93/42	EUDAMED record Report an error
Stress analysis systems	Z12050101	ST80i Stress Test System 12L Leadset, Grabber/Snaps IEC;93/42 12L Leadset, Grabber, IEC 12L Leadset, Grabber/Snaps IEC;2 refs (no longer marketed)	IIa MDR, 93/42	EUDAMED record Report an error
Biplanar angiography systems	Z11030103	Azurion 7 B1293/42	IIb 93/42	EUDAMED record Report an error
Breast pumps	Z12080303	Philips Avent Electric Breast Pump3 refs	IIa MDR	EUDAMED record Report an error
Computed tomographs - 128 layers or more but less than 256 layers	Z11030606	CT 5300 CT Scanner System (Incisive CT/CT5300)3 refs	IIb MDR	EUDAMED record Report an error
Computed tomographs - 256 layers or more	Z11030607	Brilliance iCT2 refs	IIb MDR	EUDAMED record Report an error
Computed tomographs - exceeding 2 layers but less than 16 layers	Z11030602	Access CT2 refs	IIb MDR	EUDAMED record Report an error
CT/PET systems	Z11020301	Vereos PET/CT2 refs	IIb MDR	EUDAMED record Report an error
Curvilinear transcutaneous two-dimensional ultrasound probes (convex-array)	Z110402010201	Transducer C5-13 refs	IIa MDR	EUDAMED record Report an error
ECG data management systems	Z12059009	IntelliSpace ECG Management System	IIa MDR, 93/42	EUDAMED record Report an error
Endocavitary ultrasound probes, two-dimensional	Z1104020201	Transducer 3D9-3v3 refs	IIa MDR	EUDAMED record Report an error
Gaseous exchange monitoring instruments - other	Z1203020499	IntelliVue G7m Anesthesia Gas Module	IIb MDR	EUDAMED record Report an error
Generic photostimulators	Z129005	VitalSky system93/42	IIa 93/42	EUDAMED record Report an error
Holter system instruments for cardiovascular parameters - software accessories	Z12050482	Philips Holter Software93/42	IIa 93/42	EUDAMED record Report an error
Invasive blood pressure monitoring instruments	Z1203020301	Invasive Blood Pressure Module93/42	IIb 93/42	EUDAMED record Report an error
Magnetic resonance (mr) radiofrequency volumetric coils	Z1105018002	MR coil (Smart Fit Knee 3.0T)	IIa MDR	EUDAMED record Report an error
Magnetic resonance (mr) systems - medical device software	Z11050192	RTgo3 refs	IIb MDR	EUDAMED record Report an error
Magnetic resonance (mr) systems - software accessories	Z11050182	DynaCAD 5	IIa MDR	EUDAMED record Report an error
Open magnet MRI scanners with magnetic field intensity greater than 0.5t	Z11050103	Options IB Prodiva 1.5T R53 refs	IIb MDR	EUDAMED record Report an error
Photoepilation equipment	Z12040201	Philips Lumea3 refs	IIa MDR	EUDAMED record Report an error
Portable ultrasound scanners	Z11040103	Flash Ultrasound System 5100 POC2 refs	IIa MDR	EUDAMED record Report an error
Prenatal diagnostic instruments - hardware accessories	Z12080180	Fetal Monitoring Recording Paper3 refs	I MDR	EUDAMED record Report an error
Radiotherapy simulators	Z11010201	Multimodality Simulation Workspace (MM Sim)2 refs	IIb MDR	EUDAMED record Report an error
Radiotherapy treatment planning systems	Z11010401	Pinnacle3® 16.4.393/42	IIb 93/42	EUDAMED record Report an error
Stress analysis instruments - hardware accessories	Z12050180	12L Leadset, Grabber, IEC ST80i Lead set, Grabber/Snaps2 refs	I MDR	EUDAMED record Report an error
Surgical navigation instruments - consumables	Z12011485	40001 PercuNav Coaxial Needle Tracker, 13Gx11cm3 refs	IIa MDR	EUDAMED record Report an error
Systems for direct digital radiology (dr) - hardware accessories	Z11031180	Adjustable Lateral Cassette Holder3 refs	I MDR	EUDAMED record Report an error
Transesophageal ultrasound probes, two-dimensional	Z1104020301	Transducer S7-3t3 refs	IIa MDR	EUDAMED record Report an error
Two-dimensional linear-array transcutaneous ultrasound probes	Z110402010101	Transducer L15-7io2 refs	IIa MDR	EUDAMED record Report an error
Ultrasound scanners - software accessories	Z11040182	UroNav 4	IIa MDR	EUDAMED record Report an error
Various digital bioimaging management instruments - medical device software	Z11069092	Image Management 15.X	IIb MDR	EUDAMED record Report an error
Various general purpose IVD instruments - IVD medical device software	W02079092	LABOSYS 2016.3 and higher98/79	– 98/79	EUDAMED record Report an error
Various instruments for cardiology and cardiac surgery - medical device software	Z12059092	Xper Information Management System	IIa MDR	EUDAMED record Report an error
Various ultrasound instruments - hardware accessories	Z11049080	ICE PIM	I MDR	EUDAMED record Report an error
Various ultrasound instruments - medical device software	Z11049092	Ultrasound Workspace	IIa MDR	EUDAMED record Report an error
Transcutaneous bilirubinometers No model still on the market	Z12080410	BILECLIPSE, 50 PACK (no longer marketed) Bilical, 50 Pack (no longer marketed)	I MDR	EUDAMED record Report an error
Defibrillators - software accessories No model still on the market	Z12030582	HeartStart Configure93/42 (no longer marketed)	IIb 93/42	EUDAMED record Report an error
ECG holter recorders No model still on the market	Z12050403	DigiTrak XT Holter Recorder93/42 (no longer marketed)	IIa 93/42	EUDAMED record Report an error
Measurement devices - other No model still on the market	V0399	Healthdot 3.1 (no longer marketed)	IIa MDR	EUDAMED record Report an error
Various instruments to support and monitor vital signs - software accessories No model still on the market	Z12039082	CareEvent93/42 (no longer marketed)	IIb 93/42	EUDAMED record Report an error
Various ultrasound instruments - other No model still on the market	Z11049099	Onvision System (no longer marketed)	I 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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