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Respiratory and anaesthesia devices
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Respiratory masks and balloons, single-use and reusable
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Respiratory masks
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Ventilation masks
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CPAP and niv masks
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Niv masks
Niv masks
R0301010202
360 devices
Fullface (Oranazal) Maske Si̇li̇kon Esasli Hava Kaçaksiz Large
Ece Tıbbi Cihazlar ve Medikal San. Tic. A.Ş.
·
,
Türkiye
Class IIa
CE/MDR
Oro-Nasal Mask
Hans Rudolph, Inc.
·
,
United States
Class IIa
CE/MDR
GUDID
on market
NIV Mask, S
GaleMed Corporation
·
,
Taiwan
Class IIa
CE/MDR
Mask
medin Medical Innovations GmbH
·
,
Germany
Class I
CE/MDR
Large Amara Gel Mask with Reduced Size Frame and Headgear International
Respironics Inc.
·
,
United States
Class IIa
CE/MDD
GUDID
on market
NV Quattro Air FFM LGE - EUR
Resmed Pty Ltd
·
,
Australia
Class IIa
CE/MDR
GUDID
on market
ClasStar, GanzGesMaske, NIV, SE, M
Drägerwerk AG & Co. KGaA
·
,
Germany
Class IIa
CE/MDR
Amara Gel Mask With Rs Frame And Headgear Intl, Petite
Respironics Inc.
·
,
United States
Class IIa
CE/MDD
GUDID
on market
NovaStar plus NIVMaske, AAV, M
Drägerwerk AG & Co. KGaA
·
,
Germany
Class IIa
CE/MDR
Oro-Nasal Mask
Hans Rudolph, Inc.
·
,
United States
Class IIa
CE/MDR
GUDID
on market
NIV Mask w/port, L
GaleMed Corporation
·
,
Taiwan
Class IIa
CE/MDR
DreamWear Under Nose Mask Medium Wide, Small Frame w/o Headgear, Global
Respironics Inc.
·
,
United States
Class IIa
CE/MDD
GUDID
on market
NIV mask, middle, including headgear
GaleMed (Xiamen) Co., Ltd.
·
,
China
Class IIa
CE/MDR
L, DreamWear Silicone Pillows, Large Frame with Headgear, Asian Pacific
Respironics Inc.
·
,
United States
Class IIa
FDA 510(k)
K210844
Active
Cleared 24 Aug 2021
CE/MDD
+1
authorizations
Oro-Nasal Mask
Hans Rudolph, Inc.
·
,
United States
Class IIa
CE/MDR
GUDID
on market
ClassicStar plus NIV Mund-Nasen-Maske
Drägerwerk AG & Co. KGaA
·
,
Germany
Class IIa
CE/MDR
NV Quattro Air FFM MED - EUR
Resmed Pty Ltd
·
,
Australia
Class IIa
CE/MDR
GUDID
on market
Oro-Nasal Mask
Hans Rudolph, Inc.
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Respireo Hospital F Non Vented Reusable
Air Liquide Medical Systems S.r.l.
·
,
Italy
Class IIa
CE/MDR
Oro-Nasal Mask
Hans Rudolph, Inc.
·
,
United States
Class IIa
CE/MDR
GUDID
on market
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