NIV MASKS

EMDN R0301010202

Registry term list. Not a clinical opinion. 1621 devices carry this code.

Devices

Name	UDI-DI	Manufacturer	Class	Badge
Respireo SOFT Facial Non Vented	08015662725514	Air Liquide Medical Systems S.r.l.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Respireo SOFT Facial Non Vented	08015662725521	Air Liquide Medical Systems S.r.l.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Respireo SOFT Facial Non Vented	08015662725538	Air Liquide Medical Systems S.r.l.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
S AMARA GEL MASK SE W/RS FRAME AND RS HGR INT	00606959025233	Respironics Inc.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
S COMFORTGEL BLUE SE NASAL MASK W/HGR, INTL	00606959020825	Respironics Inc.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
S DreamWear Gel Pillows Mask, Medium Frame w/Hgr, Global	00606959026896	Respironics Inc.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
SE Nebulizing Elbow Kit, 5 Pack	30606959008299	Respironics Inc.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
S FITLIFE MASK EE W/HGR INT	00606959001794	Respironics Inc.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas	08698863810243	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas	08698863810250	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas	08698863810267	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas	08698863810281	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas	08698863810298	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas	08698863810304	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas	08698863810755	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas	08698863810762	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas	08698863810830	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas	08698863810847	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas	08698863810922	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas	08698863810939	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas	08698863810946	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas	08698863810953	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas	08698863811486	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas	08698863811493	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas	08698863811509	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas	08698863811516	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas	08698863811523	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas	08698863811530	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas A1	08698863810861	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas A1	08698863810878	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Sleepas A1	08698863810885	Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
S PerforMax MPU INTL w/EE Leak 2 & SE, Plus 4 HG	00606959008007	Respironics Inc.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
TOPSONMED	06973855830679	Hebei Topson Medical Technology Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
TOPSONMED	06973855830686	Hebei Topson Medical Technology Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
TOPSONMED	06973855830693	Hebei Topson Medical Technology Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
TOTALFACE (TÜM YÜZ) MASKE SİLİKON ESASLI	08680845006393	Ece Tıbbi Cihazlar ve Medikal San. Tic. A.Ş.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Tüm Yüz (Oranazal) Maske Silikon Esaslı	08680845006157	Ece Tıbbi Cihazlar ve Medikal San. Tic. A.Ş.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Tüm Yüz (Oranazal) Maske Silikon Esaslı	08680845006164	Ece Tıbbi Cihazlar ve Medikal San. Tic. A.Ş.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Tüm Yüz (Oranazal) Maske Silikon Esaslı Large	08680845006171	Ece Tıbbi Cihazlar ve Medikal San. Tic. A.Ş.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
v	04711064682694	Hsiner Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
VariFit NIV Non Vented Mask, Extra Large	00814747024577	Sleepnet Corporation	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
VariFit NIV Non Vented Mask, Large	00814747024553	Sleepnet Corporation	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
VariFit NIV Non Vented Mask, Medium	00814747024539	Sleepnet Corporation	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
VariFit NIV Non Vented Mask, Small	00814747024515	Sleepnet Corporation	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
VariFit NIV Non Vented Mask with AAV, Extra Large	00814747024492	Sleepnet Corporation	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
VariFit NIV Non Vented Mask with AAV, Large	00814747024478	Sleepnet Corporation	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
VariFit NIV Non Vented Mask with AAV, Medium	00814747024379	Sleepnet Corporation	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
VariFit NIV Non Vented Mask with AAV, Small	00814747024355	Sleepnet Corporation	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Ventilation Mask	06974832560404	GuangDong EDA Technology Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED
Ventilation Mask	06974832560732	GuangDong EDA Technology Co., Ltd.	Class IIa	No Certificate Found Snapshot 2026-10-22 · Link to EUDAMED