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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 76 of 76

Device	Model / Reference	Registries	Class	Status
Cable, Low Level Output, 3/32" (2.381 mm) Male Phone Connector	P1077	EUDAMEDFDA UDI	Class I	Active
System One Heated Humidifier INTL	IN6H	EUDAMEDFDA UDI	Class IIa	Active
Philips NightBalance Mobile App, Android	1142207	EUDAMED	Class IIa	Active
Philips NightBalance, DE	L2EU01DE	EUDAMEDFDA UDI	Class IIa	Active
Trilogy Evo, France	FR2110X14B	EUDAMEDFDA UDI	Class IIb	Active
AW CT Takeda TAK-925-2002 Pkg Scorer	1144918	EUDAMED	Class IIa	Active
Trilogy 200 Ventilator, Germany	1032802	EUDAMEDFDA UDI	Class IIb	Active
ComfortGel Blue Mask w/SE, w/Headgear, Petite, INTL	1070071	EUDAMEDFDA UDI	Class IIa	Active
Trilogy100 Ventilator, Germany	1054097	EUDAMEDFDA UDI	Class IIb	Active
REMstar Auto A-Flex, System One 60 Series, GB	GB561S	EUDAMEDFDA UDI	Class IIa	Active
Dorma 500 Auto, with Humidifier, TR	TRV501H	EUDAMEDFDA UDI	Class IIa	Active
Actiwatch Spectrum Communication Dock System Rental	R1048093	EUDAMED	Class IIa	Active
Actiwatch 2 Communication Dock System Recertified	U1048092	EUDAMED	Class IIa	Active
S AF531 SE NE W/CapStrap, SU, 10 Pack	1100396	EUDAMED	Class IIa	Active
Dorma 500 Auto, w/ Humid, DE	DEV502H	EUDAMEDFDA UDI	Class IIa	Active
AW CT Janssen 42847922MDD1005 Scorer	1147444	EUDAMED	Class IIa	Active
Actiwatch 2 Communication Dock System	1048092	EUDAMEDFDA UDI	Class IIa	Active
DreamWear Gel Pillows Mask, M, M Frame w/o Headgr, Global	1124987	EUDAMEDFDA UDI	Class IIa	Active
Dorma 500 Auto, IN	INDV501	EUDAMEDFDA UDI	Class IIa	Active
Trilogy Evo, Benelux	BL2110X15B	EUDAMEDFDA UDI	Class IIb	Active
DreamWear Gel Pillows Mask, S, L Frame w/o Headgr, Global	1125012	EUDAMEDFDA UDI	Class IIa	Active
DreamWear Under Nose Mask Medium, Medium Frame w/o Headgear, Global	1116706	EUDAMEDFDA UDI	Class IIa	Active
Philips Basic Kit, PerformaTrak SE, INTL	1074050	EUDAMEDFDA UDI	Class IIa	Active
ComfortGel Blue Nasal Mask w/Headgear, Petite, INTL	1070067	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