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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 70 of 76

Device	Model / Reference	Registries	Class	Status
AW CT Takeda TAK-925-2001 Pkg Site	1144736	EUDAMED	Class IIa	Active
System One Heated Tube Humidfier IT	IT6T	EUDAMEDFDA UDI	Class IIa	Active
Litetouch Large Mask	1082716	EUDAMEDFDA UDI	Class I	Active
DreamWear Gel Pillow Kit S/M, w/HGR, GBL	1144025	EUDAMEDFDA UDI	Class IIa	Active
Actiware Clinical Trial Software, English - 6	1103609	EUDAMEDFDA UDI	Class IIa	Active
Double Port CPAP Titration Kit	P1327	EUDAMEDFDA UDI	Class I	Active
DreamWear Under Nose Mask L, S Frame w/Headgear, Global	1116687	EUDAMEDFDA UDI	Class IIa	Active
Litetouch Large Mask- Row	1083783	EUDAMEDFDA UDI	Class I	Active
Disposable Tubing 18 IN (46 cm)) QTY:10	312153	EUDAMED	Class IIa	Active
BiPAP A30 Ventilator, INTL	1111143	EUDAMEDFDA UDI	Class IIb	Active
Philips NightBalance, IB	L2EU01IB	EUDAMEDFDA UDI	Class IIa	Active
DreamStation 2 Auto CPAP Humidifier/Cell/Bluetooth, EU	EUX510H15C	EUDAMED	Class IIa	Active
DreamWear Under Nose Mask Large, Small Frame w/o Headgear, Global	1116712	EUDAMEDFDA UDI	Class IIa	Active
DreamWear Gel Pillows Mask, Med Frame w/Headgr, INTL	1125024	EUDAMEDFDA UDI	Class IIa	Active
DreamStation Auto CPAP, INTL	INX500S15	EUDAMEDFDA UDI	Class IIa	Active
Detachable Battery Module, USA/INTL	1096770	EUDAMEDFDA UDI	Class I	Active
FitPack, DreamWisp Nsl, Med Con w/o Hgr GBL (S, M, L Cushions)	1137918	EUDAMEDFDA UDI	Class IIa	Active
DreamWear Under Nose Mask Medium Wide, Small Frame w/o Headgear, Global	1116713	EUDAMEDFDA UDI	Class IIa	Active
DreamWear Gel Pillows Mask, M, Sm Frame w/Headgear, Global	1125019	EUDAMEDFDA UDI	Class IIa	Active
Dorma 100, INTL	INV101	EUDAMEDFDA UDI	Class IIa	Active
AW CT Takeda TAK-925-2001 Pkg Scorer	1144735	EUDAMED	Class IIa	Active
Air Flow, Cannula Sample Pack	P1258	EUDAMEDFDA UDI	Class I	Active
Actiwatch Spectrum PRO-Rental	R1099351	EUDAMED	Class IIa	Active
AW CT Janssen NOPRODBIP0001 Pkg Scorer	1131704	EUDAMED	Class IIa	Active
BiPAP Auto BiFlex, System One 60 Series, ES	ES761S	EUDAMEDFDA UDI	Class IIa	Active
InnoSpire Go LiteTouch Medium Mask	1127798	EUDAMEDFDA UDI	Class IIa	Active
Cable, Isolated, USB to RJ45	1127403	EUDAMEDFDA UDI	Class I	Active
Actiware Software Web Download - 6	1104776	EUDAMEDFDA UDI	Class IIa	Active
REMstar Auto A-Flex System One 60 Series, Italy	IT561S	EUDAMEDFDA UDI	Class IIa	Active
Philips NightBalance, Refurbishment Kit, UK	RPL2EU01UK	EUDAMED	Class IIa	Active
Garbin Plus Ventilator, International	1040002	EUDAMEDFDA UDI	Class IIb	Active
DreamStation 2 Roll Stand	1145156	EUDAMED	Class I	Active
Philips NightBalance UK	L2EU01UK	EUDAMEDFDA UDI	Class IIa	Active
BiPAP Vision Disp Circ Box/Ten	582072	EUDAMED	Class IIa	Active
Cannula, MP Nasal M-F 0.45x0.40	1139057	EUDAMED	Class IIa	Active
AW CT Janssen 42847922MDD1005 Site	1147443	EUDAMED	Class IIa	Active
CT Sanofi LPS15497 Software Pkg Site	1143211	EUDAMED	Class IIa	Active
Trilogy Evo, Italy	IT2110X21B	EUDAMEDFDA UDI	Class IIb	Active
Web, DirectView Software	1055635	EUDAMEDFDA UDI	Class I	Active
NightBalance	1145658	EUDAMED	Class IIa	Active
Trilogy100 Ventilator, Intl-Recert	U1054096	EUDAMEDFDA UDI	Class IIb	Active
DreamWear Under Nose Mask Large, Medium Frame w/Headgear, Global	1116682	EUDAMEDFDA UDI	Class IIa	Active
OmniLab Connect System	1111076	EUDAMEDFDA UDI	Class I	Active
DreamStation 2 Auto CPAP Humid/Cell/BT, IT	ITX510H15C	EUDAMED	Class IIa	Active
DreamWear Gel Pillows Mask, S, Large Frame w/Hgr, Global	1125021	EUDAMEDFDA UDI	Class IIa	Active
DreamStation 2 Auto CPAP Humid/BT only, EU	EUX510H15	EUDAMED	Class IIa	Active
Trilogy EV300, Eastern Europe	EE2200X15B	EUDAMED	Class IIb	Active
AW CT Regeneron R3500-AD-1798 Pkg Scorer	1140958	EUDAMED	Class IIa	Active
PC Direct Software	1022090	EUDAMED	Class IIb	Active
Detachable Battery Pack, USA/INTL	1043570	EUDAMEDFDA UDI	Class I	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