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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 11 of 76

Device	Model / Reference	Registries	Class	Status
DreamStation	DreamStation Auto BiPAP w/Humid w/H Tube, w/Cell, US	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP Pro with Humidifier, EE	FDA UDI	Class II	Active
System One, 50 Series	00	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP Pro w/WiFi, AHP	FDA UDI	Class II	Active
Pn841	PN841 Mask, INTL, Child Small, Leak 3, ASM	FDA UDI	Class II	Active
Amara Gel	00	FDA UDI	Class II	Active
DreamStation	DreamStation Auto BiPAP w/Humid, w/H Tube, CN	FDA UDI	Class II	Unknown
Sensor	SPI SENSOR DC	FDA UDI	Class II	Active
Af531	AF531 Mask EE,Leak 1,Circuit, Neb Elbow,Capstrap, SU, Sm, US	FDA UDI	Class II	Unknown
DreamStation	DreamStation CPAP with WiFi, USA	FDA UDI	Class II	Unknown
BiPAP AVAPS	BiPAP AVAPS C Series, 30cm, NO	FDA UDI	Class II	Active
DreamStation	DreamStation Auto CPAP, ND	FDA UDI	Class II	Active
Trilogy	00	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP Auto BiFlex, System One 60 Series, FR	FDA UDI	Class II	Unknown
DreamWear	00	FDA UDI	Class II	Active
Performatrak	PERFORMATRAK SE REUSABLE PACK, SMALL, KOREA	FDA UDI	Class II	Unknown
Care Orchestrator Denmark	1.12	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP Pro BiFlex, with Humidifier, 60 Series, CA	FDA UDI	Class II	Active
Af531	AF531 Mask EE (Nebulizing Elbow) with CapStrap, Large, USA	FDA UDI	Class II	Unknown
REMstar System One 60 Series	REMstar Pro C-Flex+, w/Humid, System One 60 Series, ES	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP Auto Bi-Flex w/ Humid, System One 60 Series, CNBiPAP Auto Bi-Flex w/ Humid	FDA UDI	Class II	Unknown
Af531	AF531Mask EE, Leak 1, Circuit, Neb Elbow, CapStrap, L, SU	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP Auto BiFlex w/H Tube Humid, St Tube, 60 Srs, CA	FDA UDI	Class II	Active
BIPAP autoSV Advanced System One 60 Series	BiPAP autoSV Advanced, 60 Series, 30 cm, INTL	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP Pro w/Humidifier, w/H Tube, KR	FDA UDI	Class II	Unknown
Trilogy	Trilogy, Mouthpiece Ventilation Disposable Circuit	FDA UDI	Class II	Active
DreamMapper Mobile App Android (EMEA)	2.9	FDA UDI	Class II	Active
Wisp	Wisp Youth Mask, Fabric, without Headgear, US	FDA UDI	Class II	Active
DreamWear	00	FDA UDI	Class II	Active
System One	System One HT Humid, Finland	FDA UDI	Class II	Active
ComfortGel Blue	ComfortGel Blue Nasal Mask w/SE, w/Headgear, Small, JP	FDA UDI	Class II	Unknown
Dorma 200	Dorma 200, US	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Pro C-Flex+, w/Humid, System One 60 Series, FI	FDA UDI	Class II	Active
ezRIP	ezRIP, Abdomen, 249, 84 inch	FDA UDI	Class II	Active
BiPAP A40	ESX3000T19	FDA UDI	Class II	Active
Pro-Flow	PRO-FLOW PLUS, NASAL ORAL , CANNULA ADULT 8.25"	FDA UDI	Class II	Active
Amara	AMARA MASK with RS FRAME and Headgear, Small, CN	FDA UDI	Class II	Unknown
PerforMax	PerforMax Mask with EE, Single Patient Use, Small, JP	FDA UDI	Class II	Active
Flow Gen, BiPAP AVAPS, USA	00	FDA UDI	Class II	Active
Simplygo Mini, Extended Battery, Fr	00	FDA UDI	Class II	Active
Dorma	Dorma 500 Auto, BR	FDA UDI	Class II	Unknown
DreamStation	DreamStation AVAPS 30 AE AAM w/Hum w/HTube, no BT, INTL	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP Auto BlueTooth, US	FDA UDI	Class II	Active
BiPAP A40	FRX3T	FDA UDI	Class II	Active
Millennium M10	Millennium M10 Oxygen Percentage Indicator Concentrator, BR	FDA UDI	Class II	Unknown
Bronchoscopy Elbow	Bronchoscopy Elbow	FDA UDI	Class II	Active
DreamStation	DreamStation Auto CPAP with Humidifier, US	FDA UDI	Class II	Active
DreamStation Go	DreamStation Go CPAP w/Bluetooth, w/Battery, US	FDA UDI	Class II	Active
CoughAssist	CoughAssist, Facemask, Adult Small	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Plus C Flex, w/Humid, System One 60 Series, PT	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