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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 69 of 76

Device	Model / Reference	Registries	Class	Status
CoughAssist, Adapter, 22mm x 15mm	1044191	EUDAMEDFDA UDI	Class IIa	Active
CoughAssist, Mouthpiece	1044821	EUDAMEDFDA UDI	Class IIa	Active
Profile Lite 2 SE with Headgear, Petite, Italy	1132188	EUDAMEDFDA UDI	Class IIa	Active
System One Heated Humidifier GER	DE6H	EUDAMEDFDA UDI	Class IIa	Active
DreamStation Cell, Dipole, EU	100625C	EUDAMEDFDA UDI	Class I	Active
Philips NightBalance, FR	L2EU01FR	EUDAMED	Class IIa	Active
Garbin Evo, Linde	LD2110X23B	EUDAMEDFDA UDI	Class IIb	Active
BiPAP A40 Ventilator, INTL	1111169	EUDAMEDFDA UDI	Class IIb	Active
Alice NightOne Non-Wireless, Warranty, INTL	1114804	EUDAMEDFDA UDI	Class IIa	Active
Ultrafill, 230v, Eu	1057124	EUDAMEDFDA UDI	Class IIb	Active
SimplyGo, Battery (Extra/Replacement)	1082662	EUDAMED	Class I	Active
REMstar Auto A-Flex, with Humidifier, 60 Series, INTL	IN561HS	EUDAMEDFDA UDI	Class IIa	Active
Portable electric ventilator	1111150	EUDAMEDFDA UDI	Class IIb	Active
Trilogy Isolated RS232 Serial Cable	1046972	EUDAMEDFDA UDI	Class I	Active
Trilogy Remote Alarm Adapter Cable	1045291	EUDAMEDFDA UDI	Class I	Active
Trilogy Evo, Great Britain	GB2110X15B	EUDAMEDFDA UDI	Class IIb	Active
Trilogy Evo O2, Great Britain	GB2100X15B	EUDAMEDFDA UDI	Class IIb	Active
Disposable Tubing 6 IN (15.2) QTY:10	312151	EUDAMED	Class IIa	Active
Actiwatch Spectrum Plus-Rental	R1101894	EUDAMED	Class IIa	Active
DreamStation Link Module	1120293	EUDAMED	Class I	Active
AW CT Vanda VP-VEC-162-3502 Pkg Site	1149117	EUDAMED	Class IIa	Active
Trilogy EV300, INTL	IN2200X15B	EUDAMED	Class IIb	Active
CPAP Titration Kit, Alice PDx	P1391	EUDAMEDFDA UDI	Class I	Active
System One HT Humid FR	FR6T	EUDAMEDFDA UDI	Class IIa	Active
ComfortGel Blue Nasal Mask w/Headgear, Small, INTL	1070066	EUDAMEDFDA UDI	Class IIa	Active
(10) BiPAP Disposable Humidifier Tubing 36 IN (91cm)	312111	EUDAMEDFDA UDI	Class IIa	Active
Whisper Swivel II Packaged	332113	EUDAMEDFDA UDI	Class IIa	Active
DreamWear Gel Pillows Mask, L, S Frame w/o Headgear, Global	1125011	EUDAMEDFDA UDI	Class IIa	Active
Dorma 100 with Humidifier, INTL	INV101H	EUDAMEDFDA UDI	Class IIa	Active
Alice NightOne, Nonin SpO2 Cable	1119823	EUDAMEDFDA UDI	Class I	Active
BiPAP A30, International-Rental	R1076491	EUDAMED	Class IIb	Active
Trilogy Evo, Medic Air	MD2110X25B	EUDAMED	Class IIb	Active
L DreamWear Gel Pillows Mask, Sm Frame w/Headgr, Global	1125020	EUDAMEDFDA UDI	Class IIa	Active
Trilogy Evo, EU	EU2110X15B	EUDAMEDFDA UDI	Class IIb	Active
DreamWear Silicone Pillows, FitPack, Asian Pacific	1146469AP	EUDAMEDFDA UDI	Class III	Active
Actiwatch 2 Device Recertified	U1048090	EUDAMED	Class IIa	Active
Actiwatch 2 Communication Dock System Rental	R1048092	EUDAMED	Class IIa	Active
Circuit Filter DEP w/FEP Filter 10PK INTL	1065830	EUDAMED	Class IIa	Active
Actiwatch 2 System	1044809	EUDAMEDFDA UDI	Class IIa	Active
DreamWear Gel Pillows Mask, Starter Pack, INTL	1136631	EUDAMEDFDA UDI	Class IIa	Active
Roll Stand, Trilogy Evo	1134429	EUDAMED	Class I	Active
CoughAssist 70 Series Circuit, Adult Medium, 9ft	1098407	EUDAMEDFDA UDI	Class IIa	Active
REMstar Plus C-Flex, 60 Series, INTL	IN261S	EUDAMEDFDA UDI	Class IIa	Active
RU Sleeping RTS, Intl	1048540	EUDAMEDFDA UDI	Class IIa	Active
External Battery Cable	1047295	EUDAMEDFDA UDI	Class I	Active
DreamStation 2 Auto CPAP Humid/Cell/BT, ND	NDX510H15C	EUDAMED	Class IIa	Active
SimplyGo External Battery Module	1109643	EUDAMED	Class I	Active
Actiwatch 2 Device	1048090	EUDAMEDFDA UDI	Class IIa	Active
System One, Heated Tube	SYS1HT15	EUDAMEDFDA UDI	Class IIa	Active
BiPAP Auto BiFlex, System One, 60 Series, IT	IT761S	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