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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 72 of 76

Device	Model / Reference	Registries	Class	Status
Trilogy Evo, Iberia	ES2110X15B	EUDAMEDFDA UDI	Class IIb	Active
InnoSpire Go EU2/ROW	1126560	EUDAMEDFDA UDI	Class IIa	Active
DreamStation Shielded DC Cord System	1120747	EUDAMED	Class I	Active
Micro-Flexible Heated 12mm Tube	HT12	EUDAMEDFDA UDI	Class IIa	Active
Trilogy 200 Ventilator, Intl-Rental	R1032800	EUDAMEDFDA UDI	Class IIb	Active
Garbin Ventilator — Bluetooth	1058180B	EUDAMEDFDA UDI	Class IIb	Active
Trilogy Evo O2, Germany	DE2100X13B	EUDAMEDFDA UDI	Class IIb	Active
Actiwatch Spectrum Device Rental	R1048091	EUDAMED	Class IIa	Active
InnoSpire Go Mask Adapter	1125985	EUDAMEDFDA UDI	Class IIa	Active
DreamWear Gel Pillows Mask, S, M Frame w/o Headgear, Global	1124986	EUDAMEDFDA UDI	Class IIa	Active
Garbin Plus Ventilator, Bluetooth, INTL	1040002B	EUDAMEDFDA UDI	Class IIb	Active
REMstar Auto A-Flex, w/Humid, System One 60 Srs, GB	GB561HS	EUDAMEDFDA UDI	Class IIa	Active
REMstar Pro C-Flex+, System One 60 Series, DE	DE462S	EUDAMEDFDA UDI	Class IIa	Active
DreamWear SP FitPack INTL	1146469	EUDAMEDFDA UDI	Class IIa	Active
AW CT Vanda VP-VEC-162-3502 Pkg Scorer	1149116	EUDAMED	Class IIa	Active
SimplyGo Mini Extended Battery Kit	1116817	EUDAMED	Class I	Active
BiPAP autoSV ADV SYS ONE 60 Series, INTL	IN961S	EUDAMEDFDA UDI	Class IIb	Active
Actiwatch Spectrum PRO	1099351	EUDAMEDFDA UDI	Class IIa	Active
Trilogy Evo, O2, EU (Non-BT)	EU2100X19	EUDAMEDFDA UDI	Class IIb	Active
AW CT Kiniksa KPL-OBS001 Pkg Scorer	1135139	EUDAMED	Class IIa	Active
Trilogy Evo, Germany	DE2110X13B	EUDAMEDFDA UDI	Class IIb	Active
CoughAssist 70 Series Circuit, Toddler, 9ft	1098404	EUDAMEDFDA UDI	Class IIa	Active
L AF531 SE NE W/CapStrap, SU, 10 Pack	1100438	EUDAMED	Class IIa	Active
Li Ion Battery Case	1126947	EUDAMED	Class I	Active
Alice 6 Therapy Circuit Interface Kit	1082653	EUDAMEDFDA UDI	Class I	Active
CT Sanofi LPS15497 Software Pkg Scorer-6	1143210	EUDAMED	Class IIa	Active
Trilogy EV300, Nordics	ND2200X15B	EUDAMED	Class IIb	Active
Ckt Filter Dep W/Fep 10pk Intl	1065836	EUDAMEDFDA UDI	Class IIa	Active
Shielded DC Cord	1001956	EUDAMED	Class I	Active
Trilogy 200 Ventilator, Germany-Rental	R1032802	EUDAMEDFDA UDI	Class IIb	Active
Trilogy 100 Ventilator, INTL-BT-RENT	R1054096B	EUDAMEDFDA UDI	Class IIb	Active
Recert-Trilogy 100 Vent, Germany -BT	U1054097B	EUDAMEDFDA UDI	Class IIb	Active
Alice PDx ExG Yoke, INTL	1048415	EUDAMEDFDA UDI	Class IIa	Active
Trilogy100 Ventilator, Bluetooth, Germany	1054097B	EUDAMEDFDA UDI	Class IIb	Active
Pediatric Mask / Small	HS81111-010	EUDAMEDFDA UDI	Class I	Active
Dorma 200 w/Humid, INTL	INV201H	EUDAMEDFDA UDI	Class IIa	Active
Alice Night One, Wireless, Ukraine	UA1114801	EUDAMED	Class IIa	Active
Actiware Software CD - 6	1104775	EUDAMEDFDA UDI	Class IIa	Active
Philips NightBalance, Refurbishment Kit, DK	RPL2EU01DK	EUDAMED	Class IIa	Active
Dorma 500 Auto, INTL	INV501	EUDAMEDFDA UDI	Class IIa	Active
Profile Lite 2 Mask with Headgear, Large, Italy	1132181	EUDAMEDFDA UDI	Class IIa	Active
Trilogy Evo, International	IN2110X15B	EUDAMEDFDA UDI	Class IIb	Active
Roll Stand, E30 Pole Bracket Assembly	1146851	EUDAMED	Class I	Active
AW CT MT-8554-E06 Pkg Scorer	1135751	EUDAMED	Class IIa	Active
zRIP DuraBelt Kit, Adult, QDC	1075968	EUDAMEDFDA UDI	Class I	Active
Actiwatch 2 Communication Dock	1046977	EUDAMEDFDA UDI	Class IIa	Active
CoughAssist 70 Series Circuit, Infant, 9ft.	1098403	EUDAMEDFDA UDI	Class IIa	Active
REMstar Pro C-Flex+, w/Humid, System One 60 Srs, GB	GB461HS	EUDAMEDFDA UDI	Class IIa	Active
BiPAP Auto BiFlex w/Humidifier System One 60 Series, GB	GB761HS	EUDAMEDFDA UDI	Class IIa	Active
PAP Li Ion Battery Kit, Sleep, NA	1124009	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