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Emdyca

Manufacturer

GE Healthcare

Austria, China, Finland, Germany, India, Japan, United StatesLegal entities : GE Healthcare Austria GmbH & Co OG, GE Healthcare Coils, GE Healthcare Finland Oy

Markets : Austria · Belgium · Denmark · Finland · France · Germany · Greece · Netherlands · Spain · Sweden · Türkiye · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 246 · PMA : 3 · class I, II, III · latest in 2026 · see on the FDA website

Public contracts won : France 125 · Germany 39 · Finland 33 · Belgium 31 · Greece 25 · Austria 23 · Denmark 2 · Netherlands 2 · Spain 1 · Sweden 1

EU representative : GE Medical Systems SCS (France)

eudamed@gehealthcare.com

30 categories, 242 models including 183 on the market, 7 countries

Export to CSV
CategoryEMDN codeRegistered modelsClassContact
Multi-parameter monitors - hardware accessories Z1203020280
70 others
 I, IIa, IIb MDR, 93/42 EUDAMED record Report an error
Magnetic resonance (mr) radiofrequency surface coils Z1105018001
22 others
 I MDR EUDAMED record Report an error
Multi-parameter monitors - consumables Z1203020285
28 others
 I, IIa, IIb MDR, 93/42 EUDAMED record Report an error
Picture archiving and communication systems Z110603
9 others
 I, IIa MDR, 93/42 EUDAMED record Report an error
Closed magnet MRI scanners with magnetic field less than or equal to 2t Z11050104
5 others
 IIa MDR EUDAMED record Report an error
Curvilinear transcutaneous two-dimensional ultrasound probes (convex-array) Z110402010201
5 others
 IIa MDR EUDAMED record Report an error
Multi-parameter patient bedside monitors Z1203020201
6 others
 IIb MDR, 93/42 EUDAMED record Report an error
Endocavitary ultrasound probes, multidimensional Z1104020202
2 others
 IIa MDR EUDAMED record Report an error
Multi-parameter monitors - software accessories Z1203020282
9 others
 I, IIa, IIb MDR, 93/42 EUDAMED record Report an error
Transcutaneous ultrasound active matrix probes, multidimensional Z110402010402 IIa MDR EUDAMED record Report an error
Two-dimensional linear-array transcutaneous ultrasound probes Z110402010101 IIa MDR EUDAMED record Report an error
Computed tomographs - 128 layers or more but less than 256 layers Z11030606 IIb MDR, 93/42 EUDAMED record Report an error
Curvilinear transcutaneous multidimensional ultrasound probes (convex-array) Z110402010202 IIa MDR EUDAMED record Report an error
Transportable/portable multi-parameter patient monitors Z1203020202 IIb MDR EUDAMED record Report an error
Computed tomographs (CT) - medical device software Z11030692 IIa MDR EUDAMED record Report an error
Endocavitary ultrasound probes, two-dimensional Z1104020201 IIa MDR EUDAMED record Report an error
Magnetic resonance (mr) systems - medical device software Z11050192 IIa MDR EUDAMED record Report an error
Multidimensional linear-array transcutaneous ultrasound probes Z110402010102 IIa MDR EUDAMED record Report an error
Multidisciplinary ultrasound scanners (internal and cardiology, etc.) Z11040104 IIa MDR EUDAMED record Report an error
Radiology instruments - medical device software Z11030592 I MDR EUDAMED record Report an error
Ultrasound probes - other Z11040299 IIa MDR EUDAMED record Report an error
Cardiotocographic telemetry instruments - consumables Z1208010485 I MDR EUDAMED record Report an error
Computed tomographs (CT) - software accessories Z11030682 IIa MDR EUDAMED record Report an error
Computed tomographs - exceeding 2 layers but less than 16 layers Z11030602 IIb 93/42 EUDAMED record Report an error
Multi-parameter monitors - medical device software Z1203020292 IIb MDR EUDAMED record Report an error
Multi-parameter monitors - other Z1203020299 I MDR EUDAMED record Report an error
Transcutaneous ultrasound sector probes (phased array), two-dimensional Z110402010301 IIa MDR EUDAMED record Report an error
Transmitting units for cardiotocographic telemetry Z1208010403 I MDR EUDAMED record Report an error
Ultrasound scanners - medical device software Z11040192 IIa MDR EUDAMED record Report an error
Various digital bioimaging management instruments - medical device software Z11069092 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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