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Emdyca

Manufacturer

Draeger

China, Germany, United StatesLegal entities : Draeger Medical Systems, Inc., Dräger Safety AG & Co. KGaA, Drägerwerk AG & Co. KGaA

Markets : Austria · Belgium · Croatia · Czechia · France · Germany · Greece · Ireland · Italy · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 155 · class I, II · latest in 2026 · see on the FDA website

Public contracts won : Italy 25 · Ireland 5 · Germany 4 · Belgium 2 · Greece 2 · Austria 1 · Croatia 1 · Czechia 1 · France 1

EU representative : Drägerwerk AG & Co. KGaA (Germany)

Website eudamed.sdmi@draeger.com

51 categories, 383 models including 343 on the market, 3 countries

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CategoryEMDN codeRegistered modelsClassContact
Vital signs monitoring instruments - hardware accessories Z12030280
60 others
I, IIb MDR, 93/42 EUDAMED record Report an error
Various instruments for anaesthesia and pulmonary ventilation support - hardware accessories Z1203019080
51 others
IIa, IIb MDR, 93/42 EUDAMED record Report an error
Electrocardiographs - hardware accessories Z12050380
27 others
I MDR EUDAMED record Report an error
Multi-parameter monitors - hardware accessories Z1203020280
15 others
IIa, IIb MDR, 93/42 EUDAMED record Report an error
Medical/medicinal gas pipeline systems and related accessories Z120309
16 others
I, IIa, IIb MDR, 93/42 EUDAMED record Report an error
Anaesthesia devices Z1203010101
16 others
IIb MDR, 93/42 EUDAMED record Report an error
Multi-parameter patient bedside monitors Z1203020201
9 others
IIa, IIb MDR, 93/42 EUDAMED record Report an error
Pulse oximeters Z1203020408
6 others
IIb 93/42 EUDAMED record Report an error
Various instruments for anaesthesia and pulmonary ventilation support - consumables Z1203019085
6 others
IIa, IIb MDR, 93/42 EUDAMED record Report an error
Non-invasive blood pressure monitoring instruments Z1203020302
8 others
I, IIb MDR, 93/42 EUDAMED record Report an error
General medicine diagnosis and monitoring instruments - medical device software Z12040192
4 others
IIa, IIb MDR, 93/42 EUDAMED record Report an error
Fixed neonatal incubators Z1208040301
2 others
IIb 93/42 EUDAMED record Report an error
Neonatal radiant warmers Z12080407
5 others
IIb MDR, 93/42 EUDAMED record Report an error
Transportable/portable multi-parameter patient monitors Z1203020202
5 others
IIb MDR, 93/42 EUDAMED record Report an error
Anaesthesia systems - hardware accessories Z1203010180
1 other
I, IIa, IIb MDR, 93/42 EUDAMED record Report an error
Invasive blood pressure monitoring instruments Z1203020301 I, IIb MDR, 93/42 EUDAMED record Report an error
Electrocardiographs - consumables Z12050385 I MDR EUDAMED record Report an error
Gaseous exchange monitoring instruments - hardware accessories Z1203020480 I, IIb MDR EUDAMED record Report an error
Pulmonary ventilators for hospital use - consumables Z1203010585 IIa, IIb MDR, 93/42 EUDAMED record Report an error
Adult and paediatric/neonatal pulmonary ventilators Z1203010504
1 other
IIb MDR, 93/42 EUDAMED record Report an error
Anaesthesia systems - other Z1203010199 IIa, IIb MDR, 93/42 EUDAMED record Report an error
Cleaning, disinfection and sterilisation instruments - hardware accessories Z12011380 I MDR EUDAMED record Report an error
Dimensional clinical parameters measuring devices - other V030299 I, IIa MDR EUDAMED record Report an error
Mobile neonatal incubators Z1208040302 IIb 93/42 EUDAMED record Report an error
Vital signs monitoring instruments - consumables Z12030285 I, IIa MDR EUDAMED record Report an error
Carbon dioxide analysers Z1203020401 IIa, IIb MDR, 93/42 EUDAMED record Report an error
Devices with measuring functions - accessories V0380 I MDR EUDAMED record Report an error
Fixed scialytic lamps Z12010701 I MDR EUDAMED record Report an error
Multi-parameter monitors - medical device software Z1203020292 IIb 93/42 EUDAMED record Report an error
Muscle stimulators Z120622 I MDR EUDAMED record Report an error
Pulmonary ventilators for hospital use - hardware accessories Z1203010580 IIa, IIb MDR, 93/42 EUDAMED record Report an error
Temperature monitoring cutaneous probes V03010201 I MDR EUDAMED record Report an error
Transcutaneous bilirubinometers Z12080410 IIa MDR EUDAMED record Report an error
Various instruments to support and monitor vital signs - hardware accessories Z12039080 IIa MDR EUDAMED record Report an error
Various instruments to support and monitor vital signs - medical device software Z12039092 IIa MDR EUDAMED record Report an error
Neonatal/paediatric pulmonary ventilators Z1203010503 IIb MDR, 93/42 EUDAMED record Report an error
Portable pulmonary ventilators Z12030104 IIb MDR EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h) W0201020101 – 98/79 EUDAMED record Report an error
Central information computing systems Z12030201 IIb MDR EUDAMED record Report an error
Continuous positive pressure equipment Z12030102 IIb MDR EUDAMED record Report an error
Electroencephalography instruments - hardware accessories Z12100380 I MDR EUDAMED record Report an error
General medicine diagnosis and monitoring instruments - hardware accessories Z12040180 IIb MDR EUDAMED record Report an error
Medical support equipment - other V0899 I MDR EUDAMED record Report an error
Neonatology instruments - hardware accessories Z12080480 IIb MDR EUDAMED record Report an error
Non-specific consumables for diagnostic instruments - other Z1399 I MDR EUDAMED record Report an error
Paediatric phototherapy equipment Z12080401 IIa 93/42 EUDAMED record Report an error
Scialytic lamp lighting systems - consumables Z12010785 I MDR EUDAMED record Report an error
Scialytic lamp lighting systems - hardware accessories Z12010780 I MDR EUDAMED record Report an error
Various instruments for anaesthesia and pulmonary ventilation support - medical device software Z1203019092 IIb MDR EUDAMED record Report an error
Various instruments to support and monitor vital signs - software accessories Z12039082 I MDR EUDAMED record Report an error
Various pneumology and respiratory physiopathology instruments - other Z12159099 IIa 93/42 EUDAMED record Report an error

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