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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 20 of 76

Device	Model / Reference	Registries	Class	Status
DreamStation	DreamStation Auto CPAP, CA	FDA UDI	Class II	Active
Amara View	00	FDA UDI	Class II	Active
DreamWisp	DreamWisp Mask, Medium, Med Connector w/Headgear, CEE	FDA UDI	Class II	Active
EncoreAnywhere	2.33	FDA UDI	Class II	Active
DreamStation	DreamStation Auto CPAP w/Humid w/Heated Tube, KR	FDA UDI	Class II	Unknown
BiPAP AVAPS	BiPAP AVAPS C Series, 30cm, CN	FDA UDI	Class II	Unknown
Trilogy	00	FDA UDI	Class II	Active
Care Orchestrator	1.14	FDA UDI	Class II	Active
DreamStation	DreamStation Wi-Fi Accessory, CN	FDA UDI	Class I	Unknown
Trilogy	Trilogy100 Ventilator, Australia	FDA UDI	Class II	Active
Af531	AF531 Mask EE, Leak 1 with 4 PT Headgear, Medium, SU	FDA UDI	Class II	Unknown
DreamWear	00	FDA UDI	Class II	Active
Af531	AF531 Mask EE, Leak 1 with 4 PT Headgear, Small, SU	FDA UDI	Class II	Unknown
DreamStation	DreamStation Auto BiPAP w/Humidifier, w/WiFi, US	FDA UDI	Class II	Active
Af541	AF541 Mask EE, Leak 1 w/ CAPSTRAP, Large, US	FDA UDI	Class II	Active
Amara Gel	AMARA GEL MASK w/SE, with RS FRAME, Headgear, Small, JP	FDA UDI	Class II	Unknown
DreamStation	DreamStation BiPAP Pro with Humidifier, GB	FDA UDI	Class II	Unknown
BiPAP A30	00	FDA UDI	Class II	Active
Alice PDx	Alice PDx LM Sensor	FDA UDI	Class II	Active
DreamStation	DreamStation Auto BiPAP w/Humid, w/H Tube, w/Cell, AHP	FDA UDI	Class II	Unknown
BiPAP autoSV Advanced System One 60 Series	BiPAP autoSV Advanced w/H Tube Humid, 60 Series, CA	FDA UDI	Class II	Unknown
PerforMax	PerforMax Mask with EE, Single Patient Use, Large, JP	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Auto C-Flex+ w/Humid, BlueTooth, 60 Srs, CA	FDA UDI	Class II	Active
DreamWear Full	DreamWear Full Mask Small, w/Medium Frame w/Headgear, Global	FDA UDI	Class II	Active
DreamStation	DreamStation Auto CPAP, DE	FDA UDI	Class II	Active
Performax	PERFORMAX PEDIATRIC SE, MPU, W/4 PT HEADGR, XSMALL	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP Pro with C-Flex, FR	FDA UDI	Class II	Unknown
BiPAP S/T C-Series	BiPAP S/T C Series, 25cm, INTL	FDA UDI	Class II	Unknown
BiPAP System One 60 Series	BiPAP Auto BiFlex System One 60 Series, AHP	FDA UDI	Class II	Active
Af531	AF531 Mask w/SE, with CapStrap, Small, USA	FDA UDI	Class II	Active
DreamStation Humidifier, INTL	00	FDA UDI	Class II	Active
REMstar SE	REMstar SE with Humidifier, with SD Slot, AH	FDA UDI	Class II	Unknown
DreamStation	DreamStation BiPAP autoSV w/Humidifier, TR	FDA UDI	Class II	Active
REMStar System One 60 Series	REMStar Auto, with BlueTooth, CA	FDA UDI	Class II	Active
Af531	AF531 Mask w/SE, w/4 PT Headgear, SU, Large, CN	FDA UDI	Class II	Unknown
DreamMapper Mobile App Android (APAC)	2.13	FDA UDI	Class II	Active
EverFlo	EverFlo w/Oxygen Percentage Indicator, 230V, AR	FDA UDI	Class II	Active
Pico	Pico Traditional Nasal Mask with Headgear, Large, INTL	FDA UDI	Class II	Active
SimplyGo Mini	SimplyGo Mini with Standard Battery, IT	FDA UDI	Class II	Active
BiPAP A40	BiPAP A40 Ventilator, INTL, AR	FDA UDI	Class II	Active
BiPAP A40	ESX3100T19	FDA UDI	Class II	Active
Af421	AF421 Mask with Standard Elbow, Large, Global	FDA UDI	Class II	Active
DreamMapper	2.7	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP, EU	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP Auto BiFlex w/Humidifier, System One 60 Series, AHP	FDA UDI	Class II	Active
DreamStation	DreamStation, BiPAP AutoSV with Humidifier, GB	FDA UDI	Class II	Active
CoughAssist	00	FDA UDI	Class II	Active
DreamStation	DreamStation Auto BiPAP with Humidifier, US	FDA UDI	Class II	Active
BiPAP A40	GBX3000S19	FDA UDI	Class II	Active
Trilogy 200	Trilogy 200 Ventilator, Japan-Rental	FDA UDI	Class II	Unknown

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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