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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 13 of 76

Device	Model / Reference	Registries	Class	Status
DreamMapper	DreamMapper Mobile App Android, Asia- Pacific Instance - 2	FDA UDI	Class II	Active
DreamStation AVAPS	00	FDA UDI	Class II	Active
DreamStation	00	FDA UDI	Class II	Active
Circuits	Circuit, Disposable, 15mm, Non-Heated, Passive	FDA UDI	Class II	Active
Trilogy	Trilogy 202 Ventilator, U.S.A.-RENTAL	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP Pro, KR	FDA UDI	Class II	Unknown
Nebulizing Elbow	SE Nebulizing Elbow Kit, US	FDA UDI	Class II	Active
DreamStation	00	FDA UDI	Class I	Active
DreamStation	DreamStation BiPAP S/T 30 AAM w/Heated Humidifier, ES	FDA UDI	Class II	Active
BiPAP A40	PPX3010S10	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Auto w/HTD Humid, BlueTooth, 60 Series, CA	FDA UDI	Class II	Active
SimplyGo	SimplyGo, SA	FDA UDI	Class II	Unknown
Trilogy Evo	KR2110X15B	FDA UDI	Class II	Active
DreamWisp	DreamWisp Mask, Large, Med Connector w/Headgear, AP	FDA UDI	Class II	Active
System One	System One Heated Humidifier, Norway	FDA UDI	Class II	Active
EncoreAnywhere	2.39	FDA UDI	Class II	Active
Care Orchestrator Japan	1.13	FDA UDI	Class II	Active
DreamStation BiPAP autoSV	DreamStation BiPAPautoSV w/Humid w/H Tube w/WiFi, US	FDA UDI	Class II	Active
Alice 6	Alice 6 Base Station, LDx, Japan	FDA UDI	Class II	Unknown
BiPAP ST C Series Argentina, 30	00	FDA UDI	Class II	Active
DreamMapper Web (APAC)	2.9	FDA UDI	Class II	Active
Amara Gel	AMARA GEL MASK with RS FRAME w/o Headgear, Small, US	FDA UDI	Class II	Active
DreamStation BiPAP AVAPS	DreamStation BiPAP AVAPS30 AAM, MedicAir, Respi Comfort	FDA UDI	Class II	Active
Sensor	AIR FLOW SENSOR 2 CH.ADULT CANN.STYLE	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP Pro w/Humid w/H Tube, AHP	FDA UDI	Class II	Unknown
Performatrak	PerformaTrak Mask, Small, Reusable Pack, INTL	FDA UDI	Class II	Active
Dream Wisp	00	FDA UDI	Class II	Active
DreamStation	DreamStation Auto BiPAP, KR	FDA UDI	Class II	Unknown
Af541	AF541 Discharge Kit, 4 Point Headgear, SM	FDA UDI	Class II	Active
REMstar	REMstar, Spain	FDA UDI	Class II	Unknown
DreamStation	00606959027251	FDA UDI	Class II	Active
Af421	AF421 Mask with Entrainment Elbow, Leak 2, Small, Global	FDA UDI	Class II	Unknown
DreamMapper	2.24	FDA UDI	Class II	Active
DreamStation	DreamStation Cellular Modem with Oximetry, US	FDA UDI	Class I	Active
REMstar System One 60 Series	REMstar Pro C-Flex+, BR	FDA UDI	Class II	Unknown
Care Orchestrator Software	1.13	FDA UDI	Class II	Active
Comfortfull 2	COMFORTFULL 2 MASK with SE, MEDIUM, CHINA	FDA UDI	Class II	Unknown
Af811	AF811 Mask with Headgear, Large, Single Use	FDA UDI	Class II	Active
Pn841	PN841 Mask, JPN, Child Med, Leak 3, ASM	FDA UDI	Class II	Active
System One	System One Heated Tube Humidifier, SE	FDA UDI	Class II	Active
DreamStation	DreamStation Auto CPAP with Humidifier, ZA	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP with Humidifier, ND	FDA UDI	Class II	Unknown
ComfortGel	00	FDA UDI	Class II	Unknown
Trilogy	Trilogy200 Ventilator, Brazil	FDA UDI	Class II	Unknown
BiPAP autoSV Advanced System One 60 Series	BiPAP autoSV Advanced System One, 60 Series, CN	FDA UDI	Class II	Unknown
Af531	AF531 Mask EE, Leak 2, with 4 PT Headgear, Small, SU	FDA UDI	Class II	Active
CoughAssist	CoughAssist Circuit Breathing F/EM2	FDA UDI	Class II	Unknown
DreamWisp	DreamWisp Mask, Small, Med Connector w/Headgear, Global	FDA UDI	Class II	Active
Pro-Flow	PRO-FLOW NASAL CANNULA, M-F 0.35 x 0.35, Single	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