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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 7 of 76

Device	Model / Reference	Registries	Class	Status
DreamWear	00	FDA UDI	Class II	Active
Care Orchestrator	1.15	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP Pro with Humidifier, CA	FDA UDI	Class II	Active
DreamStation	DreamStation Auto BiPAP with Humidifier, EU	FDA UDI	Class II	Active
Trilogy 100	Trilogy100 Ventilator, Bluetooth, Canada	FDA UDI	Class II	Active
DreamStation	DreamStation Auto CPAP w/Cell, AHP	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Pro C Flex+, System One 60 Series, ND	FDA UDI	Class II	Active
UltraFill	ULTRAFILL, US	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP autoSV, no Bluetooth, INTL	FDA UDI	Class II	Active
Wisp	Wisp Mask, Fabric Frame, without headgear, Large, US	FDA UDI	Class II	Active
Af531	AF531 Mask EE with CapStrap, Large, USA	FDA UDI	Class II	Active
Alice	Alice 6 LDxN Headbox, INTL	FDA UDI	Class II	Active
DreamWear	00	FDA UDI	Class II	Active
DreamStation	DreamStation Auto CPAP, AR	FDA UDI	Class II	Active
DreamStation	01	FDA UDI	Class II	Active
Performatrak	Performatrak SE Mask w/Headgear, Disp, MEDIUM, KR	FDA UDI	Class II	Unknown
REMstar System One 60 Series	REMstar Plus System One 60 Series US	FDA UDI	Class II	Unknown
DreamStation	00	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Plus, CN	FDA UDI	Class II	Unknown
Amara	AMARA MASK with RS FRAME w/o Headgear, Medium, US	FDA UDI	Class II	Active
DreamMapper	2.7	FDA UDI	Class II	Active
DreamMapper	DreamMapper Web, China Instance - 2	FDA UDI	Class II	Unknown
Dorma 100	Dorma 100, INTL	FDA UDI	Class II	Active
DreamStation	DreamStation Auto BiPAP w/Humid, w/H Tube, INTL	FDA UDI	Class II	Active
NightBalance	00	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP Pro BiFlex, System One 60 Series, SE	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Pro C-Flex+, w/H Tube Humid, 60 Series, AU	FDA UDI	Class II	Active
DreamStation	DreamStation AVAPS 25, No Bluetooth, EU	FDA UDI	Class II	Active
Amara	00	FDA UDI	Class II	Active
Wisp	Wisp Mask, Large, Fabric Frame, with Headgear, INTL	FDA UDI	Class II	Active
Care Orchestrator	1.4	FDA UDI	Class II	Active
DreamStation	DreamStation, BiPAP AutoSV with Humidifier, EU	FDA UDI	Class II	Active
DreamWear	00	FDA UDI	Class II	Active
Pro-Flow	PRO-FLOW PLUS N/O CANNULA A 8.25"	FDA UDI	Class II	Active
CoughAssist	CoughAssist, E70, CN	FDA UDI	Class II	Unknown
Af531	AF531 Mask w/SE, Nebulizing Elbow, w/CapStrap, Medium, SU	FDA UDI	Class II	Unknown
DreamWear Full	00	FDA UDI	Class II	Active
DreamMapper App iOS (EMEA)	2.9	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Plus, 60 Series, AHP	FDA UDI	Class II	Active
Trilogy Circuit	Trilogy Active with PAP Exhalation Circuit, Adult	FDA UDI	Class II	Active
Amara Gel	AMARA GEL MASK SE WITH RS FRAME AND HEADGEAR INTL, MEDIUM	FDA UDI	Class II	Active
Af531	AF531 Mask EE Leak 2 with 4 PT Headgear, Small, Single Use	FDA UDI	Class II	Active
zRIP	zRIP Wireset	FDA UDI	Class II	Active
BiPAP ST	00	FDA UDI	Class II	Active
DreamStation	DreamStation Auto CPAP with Humidifier, EE	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP w/WiFi, AHP	FDA UDI	Class II	Active
DreamWear Full	00	FDA UDI	Class II	Active
DreamStation 2	DreamStation 2 Auto CPAP Advanced w/ Hum	FDA UDI	Class II	Active
Pn841	00	FDA UDI	Class II	Active
DreamWear	00	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