Manufacturer

GE Medical Systems Information Technologies

United StatesLegal entities : GE Medical Systems Information Technologies, Inc.

Markets : Austria · Belgium · France · Germany · Italy · Netherlands · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 171 · PMA : 2 · class I, II, III · latest in 2026 · see on the FDA website

Public contracts won : Germany 12

EU representative : GE Medical Systems SCS (France)

eudamed@gehealthcare.com

14 categories, 44 models including 44 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
General purpose electrocardiographs	Z12050301	CAM HD CAM-142 refs Cardiosoft CASE V7.02 refs KISS+3 refs MAC 3 5 others MAC 5 A4 Resting ECG Analysis System3 refs MAC 600 MAC 7 MAC 7 15 Leads UPG KIT2 refs MAC VU360 and CAM Connect 143 refs	IIa MDR	EUDAMED record Report an error
General medicine diagnosis and monitoring instruments - hardware accessories	Z12040180	ADAPTER WALL MANOM W/ BULB TO 2T 80369-5 DINACLICK FEM - SINGLE3 refs ASSY CARE HOSE 2T NEO-SNAP 2.4M3 refs CLASSIC-CUF ISO, ADULT, DINACLICK, 23 - 33 CM, 80369-5, SINGLE3 refs CLASSIC-CUF, NEONATAL1, 1 TB NEO-SNAP, 03 - 06 CM, SINGLE3 refs DURA-CUF, ADULT LONG, 1 TB BAYONET, 23 - 33 CM, SINGLE3 refs 2 others SOFT-CUF, ADULT LONG, 1 TB BAYONET, 23 - 33 CM, ENG., SINGLE3 refs SOFT-CUF, RADIAL, DINACLICK, 26 - 36 CM, 80369-5, SINGLE	I MDR	EUDAMED record Report an error
Multi-parameter monitors - hardware accessories	Z1203020280	B1X5-F2 Second Frame B1X5-REC Recorder CARESCAPE ECG CARESCAPE Pressure CARESCAPE SpO22 refs 2 others CARESCAPE Temperature DS1 3-WAY SPLITTER CABLE3 refs	I, IIb MDR	EUDAMED record Report an error
Multi-parameter monitors - medical device software	Z1203020292	CARESCAPE Central Station2 refs CARESCAPE Gateway 5697315-002 Portrait CCS01 Portrait Core Services CSSXB2 refs	I, IIb MDR	EUDAMED record Report an error
Electrocardiographs - medical device software	Z12050392	CareIntellect MUSE EK12 Starting from V2 MUSE NX	IIa MDR	EUDAMED record Report an error
Transportable/portable multi-parameter patient monitors	Z1203020202	CARESCAPE F0 DOCK2 refs CARESCAPE PDM (Patient Data Module) Portrait VSM	IIb MDR	EUDAMED record Report an error
Central information computing systems	Z12030201	Portrait CVA01 Portrait CVAXB2 refs	IIb MDR	EUDAMED record Report an error
Multi-parameter patient bedside monitors	Z1203020201	B105M Patient Monitor B105P3 refs B105M Patient Monitor B105P B125P B105M B125M B155M3 refs	IIb MDR	EUDAMED record Report an error
Electrocardiographs - hardware accessories	Z12050380	ECG LEADWIRE SET3 refs	I MDR	EUDAMED record Report an error
Multi-parameter monitors - other	Z1203020299	Portrait CAU01	IIb MDR	EUDAMED record Report an error
Multi-parameter monitors - software accessories	Z1203020282	VSP 4.0 Upgrade Software	IIb MDR	EUDAMED record Report an error
Polygraphy systems for electrophysiological studies	Z12050703	CardioLab AltiX3 refs	IIa MDR	EUDAMED record Report an error
Polygraphy systems for haemodynamic studies	Z12050702	Mac-Lab AltiX3 refs	IIa MDR	EUDAMED record Report an error
Vital signs monitoring instruments - other	Z12030299	Unity Network ID	I MDR	EUDAMED record Report an error

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