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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 1 of 76

Device	Model / Reference	Registries	Class	Status
ALICE PDx	Alice PDx Sleep Diagnostic System, JP	FDA UDI	Class II	Unknown
Af541	00	FDA UDI	Class II	Active
DreamStation	DreamStation Auto BiPAP with Humidifier, AR	FDA UDI	Class II	Active
BiPAP S/T C-Series	BiPAP S/T C Series, 30cm, INTL, IT	FDA UDI	Class II	Unknown
DreamStation	DreamStation Auto CPAP w/Humid w/H Tube, w/WiFi, CA	FDA UDI	Class II	Active
PRI Cellular Modem	PRI Cellular Modem, US	FDA UDI	Class I	Unknown
Amara	AMARA MASK with RS FRAME w/o Headgear, Large, US	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP AutoSV, IT	FDA UDI	Class II	Active
DreamMapper Mobile App Android (DMM)	2.9	FDA UDI	Class II	Active
DreamStation	DreamStation Wi-Fi Accessory with Oximetry, EU	FDA UDI	Class I	Active
DreamStation	DreamStation BiPAP AVAPS30 AAM w/Humid w/H Tube, CA	FDA UDI	Class II	Active
BiPAP A40	ITX3000S21	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Pro C-Flex+, w/Humid System One 60 Series US	FDA UDI	Class II	Active
ALICE PDX Assembly, INTL	INTERNATIONAL	FDA UDI	Class II	Active
BiPAP A40	INX3100H19	FDA UDI	Class II	Active
DreamStation	DreamStation Auto CPAP w/Auto-Trial, w/Humidifier, CN	FDA UDI	Class II	Unknown
Af541	00	FDA UDI	Class II	Active
BiPAP S/T C-Series	BiPAP S/T C Series Core Pack with Heated Tube, 30cm, CN	FDA UDI	Class II	Unknown
Dorma	Dorma 100, LA	FDA UDI	Class II	Active
DreamStation	00	FDA UDI	Class II	Active
A Series, Sys One, Heat Tube Hum, DOM-Rent	00	FDA UDI	Class II	Active
BiPAP A30	00	FDA UDI	Class II	Active
DreamMapper	2.17	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP Pro w/Humid w/Heated Tube, CA	FDA UDI	Class II	Active
DreamWear Full	DreamWear Full Mask Mediukm, w/Small Frame w/Headgear, Global	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP Auto BiFlex, w/HTD Humid, System One 60 Srs, AHP	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP, EE	FDA UDI	Class II	Active
DreamStation	DreamStation Auto BiPAP w/Humid, w/H Tube, US	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP Pro BiFlex, w/Humid System One 60 Series, US	FDA UDI	Class II	Unknown
REMstar SE	REMstar SE with SD Slot, US	FDA UDI	Class II	Unknown
Pn841	PN841 Mask, JPN, Child Small, Leak 3, ASM	FDA UDI	Class II	Unknown
PerforMax	Performax Mask w/SE, Single Use, XXSmall, KR	FDA UDI	Class II	Unknown
Active Exhalation	Active Exhalation Device Kit	FDA UDI	Class II	Active
Pro-Flow	PRO-FLOW PLUS MULTIPURPOSE NASALORAL CANNULA ADULT	FDA UDI	Class II	Active
Pro-Flow	PRO-FLOW NASAL CANNUAL, ADULT 16"	FDA UDI	Class II	Active
DreamStation	00	FDA UDI	Class I	Active
Broadband Modem	Oximetry Accessory, EU	FDA UDI	Class I	Unknown
Care Orchestrator Essence Software	3.3	FDA UDI	Class II	Active
Amara Gel	AMARA GEL MASK with RS FRAME and Headgear, Large, JP	FDA UDI	Class II	Unknown
Alice 6	Alice 6 Base Station, LDE, Brazil	FDA UDI	Class II	Unknown
SimplyGo Mini	SimplyGo Mini with Extended Battery, IT	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP Auto BiFlex, BR	FDA UDI	Class II	Unknown
zRIP DuraBelt	ZRIP DURABELT	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP Pro BiFlex, System One 60 Series, ES	FDA UDI	Class II	Active
Sleepware	Sleepware G3 Software, (Japan Only) - 3	FDA UDI	Class II	Unknown
DreamStation	00	FDA UDI	Class I	Active
BiPAP AVAPS	BiPAP AVAPS C Series, 30cm, PT	FDA UDI	Class II	Active
Amara View	00	FDA UDI	Class II	Active
System One, 60 Series	00	FDA UDI	Class II	Active
Af531	AF531 Mask w/SE, and 4 PT Headgear, Large, Single Use	FDA UDI	Class II	Active

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FDA Establishments (1)

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Respironics, Inc. Coyol Alajuela · CR FEI 3027553886