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Respironics, Inc.

United States·US-MF-000002301

Last updated September 17, 2026

Information

Country: United States
Address: 1001, Murry Ridge Lane, Murrysville, United States
Website: n/a
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: n/a
PRRC Contact: Melissa Rosko
EUDAMED SRN: US-MF-000002301
FDA FEI Number: 3007220521
DUNS Number: 080728314

Catalogue (3774)

Page 19 of 76

Device	Model / Reference	Registries	Class	Status
DreamWisp	DreamWisp Mask, Petite, Med Connector, W/Headgear, INTL	FDA UDI	Class II	Active
ComfortGel Blue	ComfortGel Blue Nasal Mask without Headgear, Large, USA	FDA UDI	Class II	Active
ComfortGel Blue	ComfortGel Blue Nasal Mask w/o Headgear, Small, USA	FDA UDI	Class II	Active
Sensor	PLM SENSOR KIT	FDA UDI	Class II	Active
DreamStation	DreamStation Auto CPAP, AU	FDA UDI	Class II	Active
DreamWisp	DreamWisp Nasal Mask, Small, Med Connector w/Headgear, CEE	FDA UDI	Class II	Active
DreamStation	00	FDA UDI	Class II	Active
Sensor	GRASS VELCRO STRAP KIT A	FDA UDI	Class II	Active
DreamWear Gel Pillow	DreamWear Gel Pillows Mask, Large Frame w/Hgr, JP	FDA UDI	Class II	Unknown
Ac611	AC611 High Flow Nasal Cannula, 22mm (M), Medium, INTL	FDA UDI	Class I	Active
BiPAP System One 60 Series	BiPAP Pro BiFlex+, w/Humid, w/BlueTooth, 60 Series, CA	FDA UDI	Class II	Active
Af541	AF541 Mask, EE, LEAK 2, WITH CAPSTRAP, LARGE	FDA UDI	Class II	Active
REMstar SE	REMstar SE,with SD Slot, INTL	FDA UDI	Class II	Unknown
Nebulizing Elbow	Entrainment Elbow Nebulizing Kit	FDA UDI	Class II	Active
BiPAP S/T C-Series	BiPAP S/T C Series Core Pack, AHP	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Pro C-Flex+, with BlueTooth, 60 Series, CA	FDA UDI	Class II	Active
Af541	AF541 Mask EE, Leak 1 w/ CAPSTRAP, Small, US	FDA UDI	Class II	Active
DreamMapper	2.24	FDA UDI	Class II	Active
DreamStation Go	DreamStation Go Auto CPAP with Bluetooth, CH	FDA UDI	Class II	Unknown
SimplyGo Mini	SimplyGo Mini with Extended Battery, BR	FDA UDI	Class II	Unknown
DreamStation	DreamStation CPAP Pro w/WiFi, US	FDA UDI	Class II	Active
Mill, 10 Lpm, Conc Canadian	Millennium M10 Concentrator, CA	FDA UDI	Class II	Active
Amara	AMARA MASK with RS FRAME and Headgear, Medium, CN	FDA UDI	Class II	Unknown
Amara	AMARA MASK w/SE, with RS FRAME, Headgear, Large, CN	FDA UDI	Class II	Unknown
ALICE PDx	Alice PDx Sleep Diagnostic System, US	FDA UDI	Class II	Active
Amara	AMARA MASK with RS FRAME AND RS Headgear, Small, US	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP Auto BiFlex w/Humidifier, System One 60 Series, AU	FDA UDI	Class II	Unknown
CoughAssist	Smooth Bore Tube, 22mm X 36"	FDA UDI	Class II	Active
DreamStation	DreamStation Auto BiPAP with Humidifier, CA	FDA UDI	Class II	Active
Af811	AF811 with FEP Procedure Pack, Medium, SA	FDA UDI	Class II	Unknown
DreamStation	DreamStation Auto BiPAP w/WiFi, US	FDA UDI	Class II	Active
SimplyGo Mini	SimplyGo Mini, US	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP Pro, INTL	FDA UDI	Class II	Active
DreamStation BiPAP AVAPS	DreamStation AVAPS30 w/Humid w/H Tube w/Cell, US	FDA UDI	Class II	Active
Alice NightOne	Alice NightOne System, Masimo, NA	FDA UDI	Class II	Active
DreamStation	DreamStation Cellular Modem with Oximetry, AU	FDA UDI	Class I	Active
System One 60 Series	REMstar Plus, US	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP Pro with Humidifier, AU	FDA UDI	Class II	Active
BiPAP autoSV Advanced System One 60 Series	BiPAP autoSV Advanced with Humidifier, 60 Series, US	FDA UDI	Class II	Unknown
A Series	A Series System One Heated Tube Humidifier, Japan	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP Pro Bi-Flex, BlueTooth System One 60 Series, US	FDA UDI	Class II	Active
DreamMapper Web (EMEA)	2.5	FDA UDI	Class I	Active
BiPAP	CN657HS	FDA UDI	Class II	Active
DreamMapper	2.24	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP S/T30 w/Hum,no Bluetooth,AAM INTL	FDA UDI	Class II	Active
BiPAP ST	00	FDA UDI	Class II	Active
Trilogy Evo, O2	TR2100X15B	FDA UDI	Class II	Active
BiPAP AVAPS	00	FDA UDI	Class II	Active
Alice NightOne	Alice NightOne, Brazil	FDA UDI	Class II	Unknown
Optilife	00	FDA UDI	Class II	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Respironics, Inc. Coyol Alajuela · CR FEI 3027553886