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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 71 of 76

Device	Model / Reference	Registries	Class	Status
Trilogy100 Ventilator, Intl-Rental	R1054096	EUDAMEDFDA UDI	Class IIb	Active
MDreamWear Under Nose Mask Medium, Small Frame w/o Headgear, Global	1116711	EUDAMEDFDA UDI	Class IIa	Active
Trilogy Evo, EU (Non-BT)	EU2110X19	EUDAMEDFDA UDI	Class IIb	Active
Dorma 200, with Humidifier, LD	LDV201H	EUDAMEDFDA UDI	Class IIa	Active
System One Heated Tube Humidfier GB	GB6T	EUDAMEDFDA UDI	Class IIa	Active
Profile Lite 2 SE with Headgear, Small, Italy	1132187	EUDAMEDFDA UDI	Class IIa	Active
REMstar Pro C-Flex+, w/HT Humid System One 60 Series INT	IN461TS	EUDAMEDFDA UDI	Class IIa	Active
ALICE PDx Diagnostic System International, Rental	R1043844	EUDAMED	Class IIa	Active
DreamStation 2 CPAP Humid/BT only, EU	EUX410H15	EUDAMED	Class IIa	Active
Trilogy 202 Ventilator International	1040000	EUDAMEDFDA UDI	Class IIb	Active
Alice PDx Core System without Sensors, INTL	1058370	EUDAMEDFDA UDI	Class IIa	Active
Alice 5 International Headbox	1017231	EUDAMED	Class IIa	Active
Portable Battery Pack (14.4AH)	1028869	EUDAMED	Class I	Active
Dorma 500 Auto, TR	TRV501	EUDAMEDFDA UDI	Class IIa	Active
Trilogy In-Use Bag	1040420	EUDAMEDFDA UDI	Class I	Active
System One Heated Tube Humidfier INTL	IN6T	EUDAMEDFDA UDI	Class IIa	Active
Medium Comfort Classic with Headgear - Iberia	1007968	EUDAMEDFDA UDI	Class IIa	Active
Trilogy100 Ventilator, Germany-Rental	R1054097	EUDAMEDFDA UDI	Class IIb	Active
DreamWear Gel Pillows Mask, L, Med Frame w/ Headgr, Global	1125017	EUDAMEDFDA UDI	Class IIa	Active
BiPAP A40 Ventilator, FR	1111175	EUDAMEDFDA UDI	Class IIb	Active
DreamStation 2 CPAP w/ Humidifier/Cell/ Bluetooth, EE	EEX410H15C	EUDAMED	Class IIa	Active
BiPAP autoSV ADV SYS ONE w/Humid, 60 Series, GER	DE962HS	EUDAMEDFDA UDI	Class IIb	Active
Actiwatch Spectrum PRO-Recertified	U1099351	EUDAMED	Class IIa	Active
Dorma 400 w/Humid, DE	DEV402H	EUDAMEDFDA UDI	Class IIa	Active
Trilogy 200 Ventilator, INTL-Bluetooth	1032800B	EUDAMEDFDA UDI	Class IIb	Active
BiPAP A40 Silver Series	1116156	EUDAMEDFDA UDI	Class IIb	Active
System One Heated Humidifier IT	IT6H	EUDAMEDFDA UDI	Class IIa	Active
Trilogy 200 Ventilator, International	1032800	EUDAMEDFDA UDI	Class IIb	Active
zRIP DuraBelt Kit, Ped., QDC	1075967	EUDAMEDFDA UDI	Class I	Active
(10) Disposable Proximal Pressure Line Assembly	312112	EUDAMEDFDA UDI	Class IIa	Active
Philips NightBalance, Refurbishment Kit, FR	RPL2EU01FR	EUDAMED	Class IIa	Active
Alice PDx Sleep Diagnostic System, INTL	1043844	EUDAMEDFDA UDI	Class IIa	Active
EncorePro2	1054785	EUDAMEDFDA UDI	Class I	Active
ComfortGel Blue Nasal Mask w/Headgear, Large, INTL	1070064	EUDAMEDFDA UDI	Class IIa	Active
DreamWear Gel Pillows Mask, M Frame w/o Headgear, Global	1124985	EUDAMEDFDA UDI	Class IIa	Active
Pediatric Mask/Medium	HS81211-010	EUDAMEDFDA UDI	Class I	Active
DreamWear Under Nose Mask MW , S Frame w/Headgear, Global	1116688	EUDAMEDFDA UDI	Class IIa	Active
Philips NightBalance, Refurbishment Kit, NL	RPL2EU01NL	EUDAMED	Class IIa	Active
Litetouch Small Mask-Row	1083785	EUDAMEDFDA UDI	Class I	Active
DreamWear Gel Pillows Mask, M, S Frame w/o Headgear, Global	1125010	EUDAMEDFDA UDI	Class IIa	Active
AW CT TAK-994-1503 Site	1148461	EUDAMED	Class IIa	Active
Philips NightBalance NL	L2EU01NL	EUDAMED	Class IIa	Active
M AF531 SE NE W/CapStrap, SU, 10 Pack	1100397	EUDAMED	Class IIa	Active
UltraFill Tubing	1065696	EUDAMED	Class IIa	Active
Garbin Ventilator, International	1040002	EUDAMED	Class IIb	Active
REMstar Pro C-Flex+ w/SD Card, INT Rental	RIN451S	EUDAMED	Class IIa	Active
Actical Software	1081738	EUDAMEDFDA UDI	Class IIa	Active
InnoSpire Go LiteTouch Small Mask	1127822	EUDAMEDFDA UDI	Class IIa	Active
System One Heated Humidifier GB	GB6H	EUDAMEDFDA UDI	Class IIa	Active
InnoSpire Go UK/INT	1126584	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