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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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CPAP masks
CPAP masks
R0301010201
538 devices
Bi-level CPAP Mask w/port, S
GaleMed Corporation
·
,
Taiwan
Class IIa
CE/MDR
LuvOn N2 Nasal Mask
Heyer Care Co.，Ltd.
·
,
China
Class IIa
CE/MDR
Airfit F20 Non Magn Sml Quiet-Eu
Open recall
Resmed Pty Ltd
·
,
Australia
Class IIa
FDA 510(k)
×2
K153563
Active
Cleared 13 May 2016
CE/MDR
Arie Nasal Vented Mask, Medium
Sleepnet Corporation
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Ventilation Mask
GuangDong EDA Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
CE/MDD
WiZARD 320
Wellell Inc.
·
,
Taiwan
Class IIa
CE/MDD
Airfit F20 Non Magn Lge Quiet-Eu
Resmed Pty Ltd
·
,
Australia
Class IIa
CE/MDR
Respireo N
Air Liquide Medical Systems S.r.l.
·
,
Italy
Class IIa
CE/MDR
CPAP face mask
Da Chung Medical Co., Ltd.
·
,
Taiwan
Class IIa
CE/MDR
Respireo Primo N
Air Liquide Medical Systems S.r.l.
·
,
Italy
Class IIa
CE/MDR
CPAP mask
Ningbo Hanyue Medical Technology CO., LTD.
·
,
China
Class IIa
CE/MDR
GUDID
on market
CPAP face mask
Da Chung Medical Co., Ltd.
·
,
Taiwan
Class IIa
CE/MDR
CPAP Face Mask Set w/Hose, M
GaleMed Corporation
·
,
Taiwan
Class IIa
CE/MDR
Ineva N1
Air Liquide Medical Systems S.r.l.
·
,
Italy
Class IIa
CE/MDR
LuvOn P1 Nasal Pillows Mask
Heyer Care Co.，Ltd.
·
,
China
Class IIa
CE/MDR
Nebulizer mask
Medivac Surgical Pvt Ltd
·
,
India
Class IIa
CE/MDD
Silicone CPAP Mask
Xiamen Compower Medical Tech. Co., Ltd.
·
,
China
Class IIa
CE/MDR
Respireo Primo F
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
Airfit F20 For Her Sml Quiet-EU1
Resmed Pty Ltd
·
,
Australia
Class IIa
CE/MDR
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