Instruments for functional explorations and therapeutic interventionsPneumonology and respiratory physiopathology instrumentsSpirometry instruments

Spirometry instruments - consumables

EMDN code Z12150185

17 manufacturers, 56 models including 43 on the market, 12 countries

On the market in Models on the market only Manufacturer country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Manufacturer	Country	Registered models	Class	Contact
Medikro FDA	Finland	Disposable Flow Transducer M9242-WA2 refs93/42 Disposable Flow Transducer M9256-MM2 refs93/42 Disposable Flow Transducer M9256-WA3 refs93/42 M92533 refs Medikro Pressure Tube M92643 refs 5 others SpiroSafe Disposable Flow Transducer M924293/42 SpiroSafe Disposable Flow Transducers M924293/42 SpiroSafe Disposable Flow Transducers M9242-B2 refs93/42 SpiroSafe Disposable Flow Transducers M92563 refs SpiroSafe Disposable Flow Transducers M9256-A93/42	I, IIa MDR, 93/42	Website EUDAMED record Report an error
Airliquide FDA	Italy	MISCELA SPIROMETRICA D.M. MIX 193/42 MISCELA SPIROMETRICA D.M. MIX 1093/42 MISCELA SPIROMETRICA D.M. MIX 293/42 MISCELA SPIROMETRICA D.M. MIX 393/42 MISCELA SPIROMETRICA D.M. MIX 493/42 4 others MISCELA SPIROMETRICA D.M. MIX 593/42 MISCELA SPIROMETRICA D.M. MIX 693/42 MISCELA SPIROMETRICA D.M. MIX 893/42 MISCELA SPIROMETRICA D.M. MIX 993/42	IIa 93/42	Website EUDAMED record Report an error
Sibel Sau	Spain	Filtro Bacteriano-vírico 28mm3 refs Kit Filtro 28mm + Pinza nasal Pinza nasal Datospir (1u)2 refs Transductor Desechable Transductor Desechable con Filtro	I, IIa MDR	Website EUDAMED record Report an error
Nddmed FDA EU representative : NDD Medizintechnik GmbH (Germany)	Switzerland	DLCO Barriette (100 pcs)3 refs EasyOne Filter FT, 100 pcs3 refs EasyOne FlowTube (basic unit)3 refs Spirette FA Pro/LAB (basic unit)3 refs	I, IIa MDR	Website support@ndd.ch EUDAMED record Report an error
Pulmeq	Poland	Disposable bacterial/viral filters for spirometry3 refs Disposable spirometry mouthpiece3 refs Jednorazowe kształtki z pianki3 refs Jednorazowy filtr do badań spirometrycznych PQFS-2893/42 (no longer marketed) Jednorazowy filtr do badań spirometrycznych PQFS-3093/42 (no longer marketed) 8 others Jednorazowy filtr do badań spirometrycznych PQFS-30S93/42 (no longer marketed) Jednorazowy ustnik do spirometru PQUS-2093/42 (no longer marketed) Jednorazowy ustnik do spirometru PQUS-2293/42 (no longer marketed) Jednorazowy ustnik do spirometru PQUS-2693/42 (no longer marketed) Jednorazowy ustnik do spirometru PQUS-2893/42 (no longer marketed) Jednorazowy ustnik do spirometru PQUS-3093/42 (no longer marketed) Jednorazowy ustnik do spirometru PQUS-30S93/42 (no longer marketed) Jednorazowy ustnik do spirometru PQUS-3193/42 (no longer marketed)	I, IIa MDR, 93/42	Website OFFICE@PULMEQ.COM EUDAMED record Report an error
Geratherm Respiratory	Germany	Softclip Spiraflow & Softclip Set	I MDR	Website info@geratherm-respiratory.com EUDAMED record Report an error
Medical Respiratory Devices	Spain	Neumobit Neumoclip	I MDR	Website EUDAMED record Report an error
AB Medica Group	Spain	Boquillas para epirometría marca LESSA3 refs	IIa MDR	Website EUDAMED record Report an error
Asistanmedikal FDA	Türkiye	PULMONARY FUNCTION TEST MOUTHPIECE (28MM-LARGE)3 refs	IIa MDR	Website EUDAMED record Report an error
Ganshorn FDA	Germany	ScoutTube93/42	IIa 93/42	Website info@ganshorn.de EUDAMED record Report an error
Respironics Novametrix EU representative : Philips Medical Systems Nederland B.V. (Netherlands)	United States	CO2/Flow Sensor Adult3 refs	IIa MDR	eudamed@philips.com EUDAMED record Report an error
SICO Società Italiana Carburo Ossigeno	Italy	SPIROMIX DM SICO3 refs	IIb MDR	EUDAMED record Report an error
Sinmed	Poland	Klips na nos do badań spirometrycznych	I MDR	EUDAMED record Report an error
Velebit EU representative : Salus Cons Kft. (Hungary)	Serbia	Usnik za spirometriju SP-U1 16mmx65mm3 refs	I MDR	Website EUDAMED record Report an error
Xeek EU representative : MedNet EC-REP GmbH (Germany)	China	C2	I MDR	Website service@xeek.cn EUDAMED record Report an error
1M4 No model still on the market	Estonia	Disposable Nose Clip (no longer marketed) Pads for nose-clamp (no longer marketed)	I MDR	Website info@1m4.eu EUDAMED record Report an error
FIM Medical FDA No model still on the market	France	Qflow93/42 (no longer marketed)	IIa 93/42	Website contact@fim-medical.com EUDAMED record Report an error

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