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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 5 of 76

Device	Model / Reference	Registries	Class	Status
Af421	AF421 Mask with Entrainment Elbow, Leak 1, Medium, INTL	FDA UDI	Class II	Unknown
REMstar System One 60 Series	REMstar Pro C-Flex+, System One 60 Series, SE	FDA UDI	Class II	Active
DreamMapper	2.20	FDA UDI	Class II	Active
PerforMax	Performax MPU Mask, Large, with EE & SE, Leak 2, INTL	FDA UDI	Class II	Active
BiPAP A40	INX3H	FDA UDI	Class II	Active
Alice NightOne	Alice NightOne, Wireless, NA	FDA UDI	Class II	Active
DreamStation BiPAP ST30	00	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP Pro w/Humid w/Heated Tube, AU	FDA UDI	Class II	Active
Wisp	Wisp Youth Mask, Fabric, with Headgear, China	FDA UDI	Class II	Unknown
BiPAP A40	IAX3000H19	FDA UDI	Class II	Active
BiPAP A40	BiPAP A40 Ventilator, BR	FDA UDI	Class II	Unknown
DreamStation	00	FDA UDI	Class II	Active
DreamWisp	DreamWisp Mask, Petite, Med Connector w/Headgear, AP	FDA UDI	Class II	Active
SimplyGo Mini	SimplyGo Mini, JP	FDA UDI	Class II	Unknown
Dorma 500	Dorma 500 Auto, DE	FDA UDI	Class II	Active
DreamStation	00	FDA UDI	Class II	Active
DreamWear	DreamWear Full Mask, SW with S/M Frame, KR	FDA UDI	Class II	Unknown
DreamStation	DreamStation Auto CPAP w/Humid w/H Tube, w/Cell, AHP	FDA UDI	Class II	Unknown
DreamStation	DreamStation Auto CPAP w/Humid w/H Tube, w/Cell, AU	FDA UDI	Class II	Active
Pico	00	FDA UDI	Class II	Active
Pico	00	FDA UDI	Class II	Active
High Level Cable 3.5mm	PTAF 2	FDA UDI	Class II	Active
REMstar SE	REMstar SE Auto, CA	FDA UDI	Class II	Active
Alice NightOne	00	FDA UDI	Class II	Active
DreamMapper	2.20	FDA UDI	Class II	Active
BiPAP A30	00	FDA UDI	Class II	Active
DreamStation	BLX500H15MQ	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP AVAPS30 AE AAM w/Humidifier, AU	FDA UDI	Class II	Active
DreamMapper	2.7	FDA UDI	Class II	Active
Cbl, High Lev Out, 14 M Ph	00	FDA UDI	Class II	Active
DreamStation	DreamStation Cellular Modem, EU	FDA UDI	Class I	Unknown
Nebulizing Elbow	SE Nebulizing Elbow Kit, Single, KR	FDA UDI	Class II	Unknown
DreamWear	01	FDA UDI	Class II	Active
DreamStation	DreamStation Auto CPAP w/Humid w/H Tube, w/Cell, CA	FDA UDI	Class II	Active
PerformaTrak	PerformaTrak SE Basic Kit, USA	FDA UDI	Class II	Active
Ap111	AP111 Mask w/Headgr, SU, Cradles (S, M, L and LN)	FDA UDI	Class II	Active
Af531	AF531 Mask EE, Leak 1 w/ CapStrap, Small, Single Use	FDA UDI	Class II	Unknown
BiPAP System One 60 Series	BiPAP Auto BiFlex, wiith Humidifier, System One 60 Series, PT	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP w/Humidifier, w/Heated Tube, AHP	FDA UDI	Class II	Unknown
Total Face Mask	00	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP autoSV w/Humid, no Bluetooth, ZA	FDA UDI	Class II	Active
DreamStation	DreamStation Auto BiPAP w/Humid, w/H Tube, KR	FDA UDI	Class II	Unknown
DreamStation Go	DreamStation Go Auto CPAP with Bluetooth, SA	FDA UDI	Class II	Unknown
PerforMax	00	FDA UDI	Class II	Active
Pn841	PN841 Mask, JPN, Child Large, Leak 3, ASM	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP Pro, KR	FDA UDI	Class II	Unknown
Circuits	Disposable Adult Passive Circuit no H2O Trap	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP Pro wiith Humidifier, with WiFi, US	FDA UDI	Class II	Active
DreamStation	DreamStation Auto CPAP w/Humidifier, w/WiFi, FR	FDA UDI	Class II	Active
CoughAssist	CoughAssist, Facemask, Adult Medium	FDA UDI	Class II	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