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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 73 of 76

Device	Model / Reference	Registries	Class	Status
AW CT TAK-994-1503 Scorer	1148462	EUDAMED	Class IIa	Active
AW CT Kiniksa KPL-716-C001 Pkg Scorer	1134316	EUDAMED	Class IIa	Active
BiPAP A30 Ventilator Private Label, INTL	1111144	EUDAMEDFDA UDI	Class IIb	Active
DreamStation Accy Module	1123881	EUDAMED	Class I	Active
BiPAP Pro BiFlex, w/Humid System One 60 Series INT	IN661HS	EUDAMEDFDA UDI	Class IIa	Active
Trilogy EV300, Spain	ES2200X15B	EUDAMED	Class IIb	Active
AW CT Ultragenyx UX701-CL001 Pkg Scorer	1146943	EUDAMED	Class IIa	Active
Trilogy 100 Ventilator, Italy - BT	IT1054096B	EUDAMED	Class IIb	Active
Rental-DreamStation Cellular Modem, EU	R100621C	EUDAMED	Class I	Active
Dorma 200 with Humidifier, FR	FRV201H	EUDAMEDFDA UDI	Class IIa	Active
Profile Lite 2 SE with Headgear, Large, Italy	1132185	EUDAMEDFDA UDI	Class IIa	Active
Cable, 12/24V battery, With Car Adaptor	1127402	EUDAMED	Class I	Active
Trilogy 202 Ventilator, Intl-RENTAL	R1040000	EUDAMEDFDA UDI	Class IIb	Active
Trilogy Evo Wheelchair Mount	1134633	EUDAMEDFDA UDI	Class I	Active
Dorma 200 with SD Card, IT, con scheda SD, IT	ITV201	EUDAMEDFDA UDI	Class IIa	Active
AW CT Novartis CAIN457FUS06 Pkg Scorer	1137568	EUDAMED	Class IIa	Active
AW CT Janssen CNTO1275CRD3007 Pkg Scorer	1137889	EUDAMED	Class IIa	Active
CoughAssist 70 Series Circuit, Adult Small, 9ft	1098405	EUDAMEDFDA UDI	Class IIa	Active
Dorma 500 Auto, with Humidifier, IN	INDV501H	EUDAMEDFDA UDI	Class IIa	Active
Litetouch Medium Mask	1082715	EUDAMEDFDA UDI	Class I	Active
Alice NightOne, Wireless, Masimo, INTL	1133937	EUDAMEDFDA UDI	Class IIa	Active
Large Amara Gel Mask with Reduced Size Frame and Headgear International	1090426	EUDAMEDFDA UDI	Class IIa	Active
System One Heated Humidifier FR	FR6H	EUDAMEDFDA UDI	Class IIa	Active
BiPAP A40 Ventilator, IT	IT1111169	EUDAMEDFDA UDI	Class IIb	Active
Alice NightOne Wireless Device, INTL	1114801	EUDAMEDFDA UDI	Class IIa	Active
Cable, Remote Alarm, RJ9, 200Ft.	1114934	EUDAMED	Class I	Active
Cable, ExG Yoke, Alice PDx, Intl. Rental	RBR1048415	EUDAMED	Class IIa	Active
DreamStation Travel Kit, 65W P/S, EU	EU1120135	EUDAMED	Class IIa	Active
Portable electric ventilator	1111149	EUDAMEDFDA UDI	Class IIb	Active
System One 60 Series Shielded DC Cord System	1099011	EUDAMED	Class I	Active
Trilogy100 Ventilator, International	1054096	EUDAMEDFDA UDI	Class IIb	Active
Amara View Mask with Headgear, Medium, INTL	1090663	EUDAMEDFDA UDI	Class IIa	Active
DreamWear Gel Pillows Mask, M, Med Frame w/Headgr, Global	1125016	EUDAMEDFDA UDI	Class IIa	Active
Trilogy Evo, O2, INT	FX2100X15B	EUDAMEDFDA UDI	Class IIb	Active
DreamStation Cell w/Oximetry, Dipole, EU	100624C	EUDAMEDFDA UDI	Class I	Active
15mm Angled Mouthpiece	1004524	EUDAMEDFDA UDI	Class IIa	Active
DreamStation - Shielded DC Cord	1120746	EUDAMED	Class I	Active
BiPAP autoSV ADV, 60 Srs, 30cm, DE Rental	RDE962S	EUDAMED	Class IIb	Active
Profile Lite 2 Mask with Headgear, Petite, Italy	1132184	EUDAMEDFDA UDI	Class IIa	Active
Actiwatch Spectrum Plus	English	EUDAMEDFDA UDI	Class IIa	Active
AW CT Ultragenyx UX701-CL001 Pkg Site	1146944	EUDAMED	Class IIa	Active
Large mask with 22mm connector for use with Philips Respironics valved holding chambers Silicone mask 6 years to adult	HS81310EU-001	EUDAMEDFDA UDI	Class I	Active
L Comfortgel Blue Se Nasal Mask W/Hgr, Intl	1070068	EUDAMEDFDA UDI	Class IIa	Active
DreamStation Wi-Fi Accessory EU, w/PRI	100722W	EUDAMED	Class I	Active
Profile Lite 2 Mask with Headgear, Medium, Italy	1132182	EUDAMEDFDA UDI	Class IIa	Active
Philips NightBalance DK	L2EU01DK	EUDAMEDFDA UDI	Class IIa	Active
DreamWear Gel Pillows Mask, Large, L Frame w/Headgr, Global	1125023	EUDAMEDFDA UDI	Class IIa	Active
InnoSpire Go LiteTouch Large Mask	1127875	EUDAMEDFDA UDI	Class IIa	Active
ALICE PDX Portable Sleep Diagnostic System International	RBR1043844	EUDAMED	Class IIa	Active
REMstar SE with Heated Tube, with SD Slot, INTL	IN221TS	EUDAMEDFDA UDI	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