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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
Oro-Nasal Mask
Hans Rudolph, Inc.
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Ascend Full Face Vented Mask System
Sleepnet Corporation
·
,
United States
Class IIa
CE/MDR
GUDID
on market
LuvOn F2 Full Face Mask
Heyer Care Co.,Ltd.
·
,
China
Class IIa
CE/MDR
Series oro-nasal masks
Hans Rudolph, Inc.
·
,
United States
Class IIa
CE/MDR
GUDID
on market
CPAP Replacement Elbow
Techo Info Ltd
·
,
United Kingdom
Class I
CE/MDR
Exhalation port
Besmed Health Business Corp.
·
,
Taiwan
Class IIa
CE/MDD
Airtouch N30I M/Std Quiet Eu
Resmed Pty Ltd
·
,
Australia
Class IIa
CE/MDR
CPAP mask
Ningbo Hanyue Medical Technology CO., LTD.
·
,
China
Class IIa
CE/MDR
GUDID
on market
Respireo SOFT Nasal
Air Liquide Medical Systems S.r.l.
·
,
Italy
Class IIa
CE/MDR
Ineva MC1
Air Liquide Medical Systems S.r.l.
·
,
Italy
Class IIa
CE/MDR
Series oro-nasal masks
Hans Rudolph, Inc.
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Masks For Cpap
Intersurgical SpA
·
,
Italy
Class IIa
CE/MDR
Arie Full Face Vented Mask, Small
Sleepnet Corporation
·
,
United States
Class IIa
FDA 510(k)
K251847
Active
Cleared 15 Jan 2026
CE/MDR
+1
authorizations
Nebulizer Mask
Medivac Surgical Pvt Ltd
·
,
India
Class IIa
CE/MDD
Respireo SOFT Facial
Air Liquide Medical Systems S.r.l.
·
,
Italy
Class IIa
CE/MDR
Respireo Hospital F2 Vented Disposable
Air Liquide Medical Systems S.r.l.
·
,
Italy
Class IIa
CE/MDR
FitMax Headstrap
Besmed Health Business Corp.
·
,
Taiwan
Class IIa
CE/MDD
CPAP-SL Mask, S
GaleMed Corporation
·
,
Taiwan
Class IIa
CE/MDR
Arie Nasal Vented Mask, Small
Sleepnet Corporation
·
,
United States
Class IIa
CE/MDR
GUDID
on market
CPAP face mask
Da Chung Medical Co., Ltd.
·
,
Taiwan
Class IIa
CE/MDR
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