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Emdyca

Manufacturer

GE Medical Systems

China, United StatesLegal entities : GE Medical Systems CO. Ltd, GE Medical Systems LLC, GE Medical Systems, LLC

First countries of placing on the market declared in EUDAMED : Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Ireland, Poland

Public contracts won : France 382, Italy 32, Poland 16, Switzerland 2

EU representative : GE Medical Systems SCS (France)

eudamed@gehealthcare.com

27 categories, 61 models including 60 on the market, 2 countries

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CategoryEMDN codeRegistered modelsClassContact
Computed tomographs (CT) - medical device software Z11030692
3 others
 IIa, IIb MDR, 93/42 EUDAMED record Report an error
Internal ultrasound scanners Z11040101
1 other
 IIa MDR, 93/42 EUDAMED record Report an error
Two-dimensional linear-array transcutaneous ultrasound probes Z110402010101
1 other
 IIa MDR EUDAMED record Report an error
Closed magnet MRI scanners with magnetic field greater than 2t and less than or equal to 4t Z11050105 IIa MDR EUDAMED record Report an error
Magnetic resonance (mr) radiofrequency surface coils Z1105018001 I MDR EUDAMED record Report an error
CT/PET systems Z11020301 IIb MDR EUDAMED record Report an error
Magnetic resonance (mr) systems - hardware accessories - other Z1105018099 I MDR EUDAMED record Report an error
Multi-parameter monitors - hardware accessories Z1203020280 I, IIb MDR EUDAMED record Report an error
Cardiology ultrasound scanners Z11040102 IIa MDR EUDAMED record Report an error
Endocavitary ultrasound probes, two-dimensional Z1104020201 IIa MDR EUDAMED record Report an error
Mobile radiographic units Z11039016 IIb MDR, 93/42 EUDAMED record Report an error
Portable ultrasound scanners Z11040103 IIa MDR, 93/42 EUDAMED record Report an error
X-ray tube assembly Z11039012 IIb MDR EUDAMED record Report an error
Anaesthesia devices Z1203010101 IIb MDR EUDAMED record Report an error
Closed magnet MRI scanners with magnetic field greater than 4t Z11050106 IIa MDR EUDAMED record Report an error
Closed magnet MRI scanners with magnetic field less than or equal to 2t Z11050104 IIa MDR EUDAMED record Report an error
Computed tomographs - 128 layers or more but less than 256 layers Z11030606 IIb MDR EUDAMED record Report an error
Computed tomographs - 256 layers or more Z11030607 IIb MDR EUDAMED record Report an error
Curvilinear transcutaneous multidimensional ultrasound probes (convex-array) Z110402010202 IIa MDR EUDAMED record Report an error
Endocavitary ultrasound probes, multidimensional Z1104020202 IIa MDR EUDAMED record Report an error
Magnetic resonance (mr) radiofrequency volumetric coils Z1105018002 IIa MDR EUDAMED record Report an error
Magnetic resonance (mr) systems - medical device software Z11050192 IIa MDR EUDAMED record Report an error
MRI/PET systems Z11020701 IIa MDR EUDAMED record Report an error
Multi-parameter patient bedside monitors Z1203020201 IIb MDR EUDAMED record Report an error
Positron emission tomography instruments - medical device software Z11020492 IIa 93/42 EUDAMED record Report an error
Transcutaneous ultrasound sector probes (phased array), two-dimensional Z110402010301 IIa MDR EUDAMED record Report an error
Various radiodiagnostic and interventional instruments - medical device software Z11039092 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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