Instruments to support and monitor vital signsAnaesthesia and pulmonary ventilation support instrumentsPulmonary ventilators for hospital use

Adult and paediatric/neonatal pulmonary ventilators

EMDN code Z1203010504

36 manufacturers, 133 models including 125 on the market, 15 countries

On the market in Models on the market only Manufacturer country

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Manufacturers registered in Europe (EUDAMED) 36

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
ResMed FDA EU representative : ResMed SAS (France)	Australia	Astral 100 - DEU Astral 100/15093/42 Astral 100 - EUR1 Astral 100/15093/42 Astral 100 - EUR2 Astral 100/15093/42 Astral 100 - EUR3 Astral 100/15093/42 Astral 100 - EUR4 Astral 100/15093/42 20 others Astral 100 - FRA Astral 100/15093/42 Astral 100 SC - DEU Astral 100/15093/42 Astral 150 - DEU Astral 100/15093/42 Astral 150 - EUR1 Astral 100/15093/42 Astral 150 - EUR2 Astral 100/15093/42 Astral 150 - EUR3 Astral 100/15093/42 Astral 150 - FRA Astral 100/15093/42 Astral 150 -EUR4 Astral 100/15093/42 LUMIS 100 VPAP ST EUR3 UB Lumis 100 VPAP S , Lumis 100 VPAP ST , Lumis 150 VPAP ST3 refs LUMIS 100 VPAP ST-A EUR2 Lumis 150 VPAP ST-A , Lumis 100 VPAP ST-A3 refs Lumis 150 VPAP ST EUR1 Lumis 100 VPAP S,Lumis 100 VPAP ST,Lumis 150 VPAP ST93/42 Stellar 100 - Eur G1 Stellar 100/130/15093/42 Stellar 100 - France Stellar 100/130/15093/42 Stellar 100 - UK Stellar 100/130/15093/42 STELLAR 130 GERMANY Stellar 100/130/15093/42 Stellar 150 Europe Grp1 Stellar 100/130/15093/42 Stellar 150 Europe Grp2 Stellar 100/130/15093/42 Stellar 150 France Stellar 100/130/15093/42 Stellar 150 Germany (GmbH) Stellar 100/130/15093/42 Stellar 150 UK Stellar 100/130/15093/42	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Foras	Türkiye	BiNefes SV-10093/42 BiNefes T1993/42 BiNefes T2393/42 DEM SV-10093/42 DEM T1993/42 13 others DEM T2393/42 Foras SV-10093/42 Foras T1993/42 Foras T2393/42 SAHRA SV-10093/42 SAHRA T1993/42 SAHRA T2393/42 TRVENT SV-10093/42 TRVENT T1993/42 TRVENT T2393/42 Ventilas SV-10093/42 Ventilas T1993/42 Ventilas T2393/42	IIb 93/42	Website info@foras.com.tr EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Ventilator SV30093/42 Ventilator SV300 Pro93/42 Ventilator SV35093/42 Ventilator SV350 Pro93/42 Ventilator SV60093/42 5 others Ventilator SV65093/42 Ventilator SV80093/42 Ventilator SV85093/42 Ventilator SynoVent E393/42 Ventilator SynoVent E593/42	IIb 93/42	Website EUDAMED record Report an error
Fisher & Paykel Healthcare FDA EU representative : FISHER & PAYKEL HEALTHCARE SAS (France)	New Zealand	F&P AIRVO 2 PT101EW93/42 F&P AIRVO 2 PT101UK93/42 F&P AIRVO 33 refs F&P AIRVO 3 JUNIOR PT321UK93/42 F&P AIRVO 3 NIV PT311EW93/42 3 others F&P MYAIRVO 2 PT100EW93/42 F&P NEOPUFF F&P NEOPUFF RD900AFU93/42	IIa, IIb MDR, 93/42	Customer.CareNZ@fphcare.co.nz EUDAMED record Report an error
Dima Italia FDA	Italy	BB Respirator2 refs93/42 LUNA 10093/42 LUNA 15093/42 Multilevel Night & Day ST3093/42 Multilevel Night & Day ST30V93/42 2 others Multilevel Night & Day ST4093/42 Multilevel Night & Day ST40V93/42	IIb 93/42	EUDAMED record Report an error
Resvent FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	RS10093/42 RS20093/42 RS30093/42 RV10093/42 RV20093/42 1 other Ventilator RS3003 refs	IIb MDR, 93/42	Website info@resvent.com EUDAMED record Report an error
Fritz Stephan	Germany	EVE IN2 refs EVE NEO + Masimo rainbow SET2 refs Oxylog 600 IC3 refs Stephanie 4G	IIb MDR	Website info@stephan-gmbh.com EUDAMED record Report an error
Shenzhen Comen Medical Instruments FDA EU representative : Lotus NL B.V. (Netherlands)	China	Emergency and Transport Ventilator V13 refs Ventilator V23 refs Ventilator V33 refs Ventilator V83 refs	IIb MDR	EUDAMED record Report an error
Draeger FDA	Germany	Evita V600 304022FK19Z0002 refs Savina 300 41162893/42 Savina 300, System 25142293/42 Evita V300 38935493/42 (no longer marketed) Savina System 01640393/42 (no longer marketed) 1 other Workstation Critical Care 04226693/42 (no longer marketed)	IIb MDR, 93/42	Website EUDAMED@draeger.com EUDAMED record Report an error
Airliquide FDA	France	Monnal T6093/42 MONNAL T60 ADVANCED3 refs MONNAL TEO5 refs MONNAL TEO NF93/42 (no longer marketed)	IIb MDR, 93/42	EUDAMED record Report an error
Ehyadarman EU representative : CERT3GLOBAL, UNIPESSOAL, LDA. (Portugal)	Iran	EDP-TS93/42 Vania93/42 Venus93/42	IIb 93/42	Website qa@ehyadarman.com EUDAMED record Report an error
Ambulanc (Shenzhen) Tech EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Transport Ventilator 6000S93/42 Ventilator T6	IIb MDR, 93/42	Website info@amoulmed.com EUDAMED record Report an error
Atlantamed EU representative : Casus Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	Diomede93/42 Dion93/42	IIb 93/42	Website info@atlantamed.co.uk EUDAMED record Report an error
Dixion	Germany	DIXION Aeros 4600 DIXION Aeros 4800	IIb MDR	Website info@dixion.de EUDAMED record Report an error
HEYER Medical EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Ventilator VG55、VG653 refs Ventilator VT80002 refs	IIb MDR	Website EUDAMED record Report an error
Loewensteinmedical FDA	Germany	elisa 300/5002 refs elisa 600/8003 refs	IIb MDR	Website info.steinbach@loewensteinmedical.com EUDAMED record Report an error
Maquet Critical Care FDA	Sweden	Servo-c Ventilator System2 refs Servo-n Ventilator System3 refs	IIb MDR	EUDAMED record Report an error
Nihon Kohden OrangeMed FDA EU representative : NIHON KOHDEN EUROPE GmbH (Germany)	United States	Nihon Kohden NKV-440 Ventilator System Nihon Kohden NKV-550 Series Ventilator System3 refs	IIb MDR	Website EUDAMED record Report an error
Penlon FDA EU representative : Obelis s.a. (Belgium)	United Kingdom (ex Northern Ireland)	AV-S Anaesthesia Ventilator93/42 AV-S MRI Anaesthesia Ventilator93/42	IIb 93/42	Website EUDAMED record Report an error
Pooyandegan rah saadat EU representative : Trionara Technologies AB (Sweden)	Iran	SAADAT Respina P1 SAADAT Respina P2	IIb MDR	Website EUDAMED record Report an error
Siare	Italy	ARIA 104 ICU LINE3 refs SIARETRON 1000 IPER	IIb MDR	Website EUDAMED record Report an error
Aeonmed EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Ventilator VG702 refs	IIb MDR	Website EUDAMED record Report an error
AgVa Healthcare EU representative : CEpartner4U (Netherlands)	India	AgVa Pro , AgVa Pro +, AgVa Intelli ,AgVa Emergency , AgVa Home & AgVa One2 refs	IIb MDR	Website info@agvahealthtech.com EUDAMED record Report an error
Beijing Eternity Electronic Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Ventilator SH300，SH3203 refs	IIb MDR	Website EUDAMED record Report an error
Beijing Siriusmed Medical Device EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	R5593/42	IIb 93/42	service@siriusmedica.com EUDAMED record Report an error
Covidien FDA EU representative : Medtronic B.V. (Netherlands)	United States	Puritan Bennett 980 Ventilator System3 refs	IIb MDR	EUDAMED record Report an error
Mekics FDA EU representative : Obelis s.a. (Belgium)	South Korea	MV200093/42	IIb 93/42	Website EUDAMED record Report an error
Micomme EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Non-invasive Ventilator ST-30H, ST-30K, ST-30C	IIa MDR	Website service@micommed.com EUDAMED record Report an error
MS Westfalia	Germany	Jenny Defibrillator Module paddle version3 refs	IIb MDR	EUDAMED record Report an error
Nanjing Chenwei medical equipment EU representative : Kingsmead Service B.V. (Netherlands)	China	CWH-301093/42	IIb 93/42	EUDAMED record Report an error
Progetti	Italy	Lung Ventilator93/42	IIb 93/42	Website info@progettimedical.com EUDAMED record Report an error
Prunusmedical FDA EU representative : Wellkang Ltd (Northern Ireland)	China	Padus 6, Padus 7, Padus 8, Padus 5, Padus 5 Pro, Padus 5m, PN50, PN55, PN60, PN65	IIb MDR	Website EUDAMED record Report an error
Respironics FDA EU representative : Respironics Deutschland GmbH & Co.KG (Germany)	United States	CoughAssist E70 Accessories CA70 SERIES,CIRCUIT,ADULT LG.,6FT93/42	IIb 93/42	eudamed@philips.com EUDAMED record Report an error
Tecme FDA EU representative : Emergo Europe B.V. (Netherlands)	Argentina	NEUMOVENT2 refs93/42	IIb 93/42	Website EUDAMED record Report an error
Utastech	Slovakia	UTAS3 refs93/42	IIb 93/42	Website info@utastech.eu EUDAMED record Report an error
Origin Medical Devices FDA EU representative : Donawa Lifescience Consulting Srl (Italy) No model still on the market	United States	Panther 3 Ventilator93/42 (no longer marketed) Panther 3V ventilator93/42 (no longer marketed) Panther 5 Ventilator93/42 (no longer marketed) Panther 5N Ventilator93/42 (no longer marketed)	IIb 93/42	Website 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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