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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 75 of 76

Device	Model / Reference	Registries	Class	Status
AW CT Takeda TAK-994-1501 Pkg Site	1143718	EUDAMED	Class IIa	Active
02 Enrichment Attachmnt Sngl	312710	EUDAMEDFDA UDI	Class IIa	Active
Trilogy Evo, O2, EU	EU2100X15B	EUDAMEDFDA UDI	Class IIb	Active
Trilogy Evo, O2, International (Non-BT)	IN2100X19	EUDAMED	Class IIb	Active
BiPAP A30, Vitalaire Vitalvent 30	1111144V	EUDAMEDFDA UDI	Class IIb	Active
Actiwatch 2 Device-Rental	R1048090	EUDAMED	Class IIa	Active
Humidifier Oxigen Salud	XS6H	EUDAMEDFDA UDI	Class IIa	Active
Philips NightBalance, Refurbishment Kit, DE	RPL2EU01DE	EUDAMED	Class IIa	Active
Trilogy Evo In-Use Case	1133930	EUDAMEDFDA UDI	Class I	Active
Trilogy Evo, INT	FX2110X15B	EUDAMEDFDA UDI	Class IIb	Active
Trilogy EV300, EU	EU2200X15B	EUDAMED	Class IIb	Active
Trilogy Evo, International (Non-BT)	IN2110X19	EUDAMED	Class IIb	Active
REMstar Auto A-Flex, System One 60 Series, Germany	DE562S	EUDAMEDFDA UDI	Class IIa	Active
CoughAssist 70 Series Circuit, Mouthpiece, 9ft	1098410	EUDAMEDFDA UDI	Class IIa	Active
DreamStation 2 CPAP Humid/BT only, IT	ITX410H15	EUDAMED	Class IIa	Active
CoughAssist 70 Series Circuit, Trach, 9ft	1098409	EUDAMEDFDA UDI	Class IIa	Active
Dorma 100 IT	ITV101	EUDAMEDFDA UDI	Class IIa	Active
DreamStation Wifi Accesory, KR	100775W	EUDAMEDFDA UDI	Class I	Active
DreamWear Under Nose Mask MW, M Frame w/Headgear, Global	1116683	EUDAMEDFDA UDI	Class IIa	Active
Alice NightOne, Non-Wireless Device, INTL	1114803	EUDAMEDFDA UDI	Class IIa	Active
BiPAP autoSV ADV 60 Series, 30cm DE	DE962XS	EUDAMEDFDA UDI	Class IIb	Active
AW CT Insmed INS 416 Pkg Site	1149189	EUDAMED	Class IIa	Active
Alice LE System INTL	1002288	EUDAMED	Class IIa	Active
Dorma 200, LD	LDV201	EUDAMEDFDA UDI	Class IIa	Active
DreamStation Wifi Accessory w/Ox, KR	100770W	EUDAMEDFDA UDI	Class I	Active
Dream Station Module	1147056	EUDAMEDFDA UDI	Class I	Active
Disposable Proximal Pressure Line, 84 in (213.36 cm)	312121	EUDAMEDFDA UDI	Class IIa	Active
AW CT Ovid OV101-17-002 Pkg Scorer	1140325	EUDAMED	Class IIa	Active
Trilogy 100 Ventilator, INTL — Bluetooth	1054096B	EUDAMED	Class IIb	Active
Humidifier Tubing, 36 inch (91 cm)	1005905	EUDAMED	Class IIa	Active
BiPAP A40, International-Rental	R1111169	EUDAMED	Class IIb	Active
Dorma 200, FR	FRV201	EUDAMEDFDA UDI	Class IIa	Active
Contour Deluxe Su W/Headgear, P, Dom/Int – 5 Pack	1016980	EUDAMED	Class IIa	Active
DreamWear Gel Pillows Mask, M, L Frame w/o Headgr, Global	1125013	EUDAMEDFDA UDI	Class IIa	Active
Garbin Ventilator, Bluetooth, DE	1040001B	EUDAMEDFDA UDI	Class IIb	Active
REMstar Plus C-Flex, w/H Tube Humid, 60 Series, INTL	IN261TS	EUDAMEDFDA UDI	Class IIa	Active
Philips NightBalance, Refurbishment Kit, IB	RPL2EU01IB	EUDAMED	Class IIa	Active
Trilogy EV300, EU (Non-BT)	EU2200X19	EUDAMED	Class IIb	Active
Li Ion Battery, Sleep, International	1126942	EUDAMEDFDA UDI	Class I	Active
BiPAP autoSV ADV w/ HT Humid, 60 Series, 30cm INTL	IN961XTS	EUDAMEDFDA UDI	Class IIb	Active
FitLife Mask with SE, with Headgear, XLarge, INTL	1089995	EUDAMEDFDA UDI	Class IIa	Active
Dorma 500 Auto, with Humidifier, INTL	INV501H	EUDAMEDFDA UDI	Class IIa	Active
M Comfortgel Blue Se Nasal Mask W/Hgr, Intl	1070069	EUDAMEDFDA UDI	Class IIa	Active
REMstar Pro C-Flex+, System One 60 Series, GB	GB461S	EUDAMEDFDA UDI	Class IIa	Active
M DreamWear Under the Nose Nasal, Med Frame W/HGR, GBL	1116681	EUDAMEDFDA UDI	Class IIa	Active
Actiwatch Spectrum Plus-Recertified	U1101894	EUDAMED	Class IIa	Active
EncoreBasic	1068689	EUDAMEDFDA UDI	Class I	Active
Trilogy 100 Ventilator, INTL — Bluetooth	1054096B	EUDAMEDFDA UDI	Class IIa	Active
BiPAP A40, Silver Series - RENTAL	R1116156	EUDAMED	Class IIb	Active
Actical-Rental	R1081737	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