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Medical equipment and related accessories, software and consumables
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Instruments for functional explorations and therapeutic interventions
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Pneumonology and respiratory physiopathology instruments
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Spirometry instruments
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Clinical/diagnostic spirometers
Clinical/diagnostic spirometers
Z12150101
86 devices
MasterScope CT
eResearchTechnology GmbH
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
smart pft USB
medical equipment europe GmbH
·
,
Germany
Class IIa
CE/MDD
MESI mTABLET SPIRO diagnostic system
MESI, razvoj medicinskih naprav, d.o.o.
·
,
Slovenia
Class IIa
CE/MDR
MDR-005
Active
Valid to Dec 2028
FDA 510(k)
K251777
Active
Cleared 2 Mar 2026
MasterScope WSSU
eResearchTechnology GmbH
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
Spirometer
Suzhou Beneware Medical Equipment Co., Ltd.
·
,
China
Class IIa
CE/MDD
Spirometer
Medcaptain Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
M920-E
Medikro Oy
·
,
Finland
Class IIa
CE/MDD
Spirovit Sp-1 G2
Schiller AG
·
,
Switzerland
Class IIa
CE/MDD
microQuark
COSMED Srl
·
,
Italy
Class IIa
FDA 510(k)
K020745
Active
Cleared 2 Jan 2003
CE/MDR
+1
authorizations
SpiroSonic AIR
Uscom Kutató, Fejlesztő és Gyártó Korlátolt Felelősségű Társaság
·
,
Hungary
Class IIa
CE/MDD
Spiro Lenis
Jnbio
·
,
South Korea
Class IIa
CE/MDR
CE/MDD
MasterScope WSSU
eResearchTechnology GmbH
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
Spirometer
Medcaptain Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
SpiroSphere
eResearchTechnology GmbH
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
MasterScope CT
eResearchTechnology GmbH
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
Spirometer
Suzhou Beneware Medical Equipment Co., Ltd.
·
,
China
Class IIa
CE/MDD
Medikro® Pro
Medikro Oy
·
,
Finland
Class IIa
CE/MDD
Spirometer
Medcaptain Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
Ert Pt
eResearchTechnology GmbH
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
Pneumotach
eResearchTechnology GmbH
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
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