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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 74 of 76

Device	Model / Reference	Registries	Class	Status
Actiwatch Spectrum Communication Dock System Recertified	U1048093	EUDAMED	Class IIa	Active
REMSTAR HEATED HUMIDIFIER INTL - RP Kit	1038807	EUDAMED	Class IIa	Active
Heated Humidifier ES	ES6H	EUDAMEDFDA UDI	Class IIa	Active
Cable, Isolated, USB to DB9	1127405	EUDAMED	Class I	Active
CT XyloCor XC001-1001 SW Pkg Scorer	1143903	EUDAMED	Class IIa	Active
Actiwatch Spectrum Device	1048091	EUDAMED	Class IIa	Active
DreamStation 2 Auto CPAP Humid/BT only, IT	ITX510H15	EUDAMED	Class IIa	Active
Software, EncorePro2, Web	1099731	EUDAMEDFDA UDI	Class I	Active
Roll Stand O2 Tank Holder BiPAP A-series	1115269	EUDAMED	Class I	Active
Trilogy 200 Ventilator Germany Bluetooth	1032802B	EUDAMEDFDA UDI	Class IIb	Active
Trilogy Remote Alarm RJ9 to BNC Cable Assembly	1079886	EUDAMED	Class I	Active
Dorma 100, Oxigen Salud	XSV101	EUDAMEDFDA UDI	Class IIa	Active
BiPAP A30, Linde Eolus 30	1111144L	EUDAMEDFDA UDI	Class IIb	Active
Li Ion Battery, BiPAP Device Cable	1121879	EUDAMED	Class I	Active
Contour Deluxe Su W/Headgear, M/L, Int	1016695	EUDAMED	Class IIa	Active
BiPAP A40 Sapio Belife	1111170S	EUDAMEDFDA UDI	Class IIb	Active
ComfortGel Blue Nasal Mask w/Headgear, Medium, INTL	1070065	EUDAMEDFDA UDI	Class IIa	Active
Respiratory Li Ion Battery Kit, NA	1124010	EUDAMEDFDA UDI	Class I	Active
ActiWatch Spectrum System	1046964	EUDAMED	Class IIa	Active
DreamWear Gel Pillows Mask, L, L Frame w/o Headgear, Global	1125014	EUDAMEDFDA UDI	Class IIa	Active
Trilogy100 Ventilator, Germany-Recert	U1054097	EUDAMEDFDA UDI	Class IIb	Active
Actiwatch Spectrum Communication Dock	1046978	EUDAMED	Class IIa	Active
Dorma 200, INTL	INV201	EUDAMEDFDA UDI	Class IIa	Active
AW CT Ovid OV101-17-001 Pkg Scorer	1138806	EUDAMED	Class IIa	Active
DreamStation Cellular Modem, KR	100675C	EUDAMEDFDA UDI	Class I	Active
Li Ion Battery, Trilogy Cable	1121737	EUDAMED	Class I	Active
Trilogy 200 Ventilator, INTL-Bluetooth	1032800B	EUDAMED	Class IIb	Active
Contour Deluxe Su W/Headgear, S, Int – 10 Pack	1016698	EUDAMED	Class IIa	Active
DreamWear Gel Pillows Mask, S, S Frame w/o Headgr, Global	1125009	EUDAMEDFDA UDI	Class IIa	Active
Ca70 Series, Circuit, Adult Lg., 6ft	1090834	EUDAMEDFDA UDI	Class IIb	Active
BiPAP A30-S Silver Series - RENTAL	R1111150	EUDAMED	Class IIb	Active
Auto DC Cable Adapter	1067424	EUDAMEDFDA UDI	Class I	Active
Trilogy Evo O2, Benelux	BL2100X15B	EUDAMEDFDA UDI	Class IIb	Active
Alice 5 International Base Unit Only	1017230	EUDAMED	Class IIa	Active
Trilogy 200 Ventilator, AERIS 200-BT	1125564B	EUDAMED	Class IIb	Active
RJ9 to 1/4" Nurse Call Cable Alarm - Closed	1080247	EUDAMEDFDA UDI	Class I	Active
DreamWear Gel Pillows Mask, Medium Frame w/Hgr, Global	1124984	EUDAMEDFDA UDI	Class IIa	Active
DreamStation Wi-Fi Accessory with Oximetry, EU	100721W	EUDAMEDFDA UDI	Class I	Active
S DreamWear Gel Pillows Mask, Medium Frame w/Hgr, Global	1125015	EUDAMEDFDA UDI	Class IIa	Active
Actiwatch Spectrum Device Recertified	U1048091	EUDAMED	Class IIa	Active
Cable, USB to CO2 Monitor	1127404	EUDAMEDFDA UDI	Class I	Active
DreamStation Cell, Dipole, EU, Rental	R100625C	EUDAMED	Class I	Active
BiPAP A-Series Power Supply	1081167	EUDAMED	Class I	Active
DreamWear Gel Pillows Mask, S, Small Frame w/Hgr, Global	1125018	EUDAMEDFDA UDI	Class IIa	Active
Detachable Battery Module	3000DBM	EUDAMEDFDA UDI	Class I	Active
DreamStation 2 Auto CPAP Advanced Humid/Cell/BT, ES	ESX520H15C	EUDAMED	Class IIa	Active
LifeVent200 Ventilator, Sapio, Bluetooth	SP1032800B	EUDAMEDFDA UDI	Class IIb	Active
AW CT Janssen 42847922MDD3001 Scorer	1147949	EUDAMED	Class IIa	Active
L, DreamWear Under the Nose Nasal, Lg Frame W/O HGR, GBL	1116717	EUDAMEDFDA UDI	Class IIa	Active
Actiwatch Spectrum Communication Dock System	1048093	EUDAMED	Class IIa	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