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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 24 of 76

Device	Model / Reference	Registries	Class	Status
DreamStation	DreamStation CPAP w/Humidifier, w/H Tube, w/Cell, AHP	FDA UDI	Class II	Unknown
Easylife	EasyLife Mask w/Headgear, Petite, Japan	FDA UDI	Class II	Unknown
DreamMapper	2.24	FDA UDI	Class II	Active
DreamMapper iOS China Instance v 2.11	2.11	FDA UDI	Class II	Active
Performatrak	PERFORMATRAK FULL FACE MASK W CAPSTRAP,JP, SMALL	FDA UDI	Class II	Unknown
EncoreAnywhere	2.38	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP AutoBiFlex w/H Tube Humid, BTooth, 60 Srs, CA	FDA UDI	Class II	Active
Sleepware	3.8	FDA UDI	Class II	Active
BiPAP autoSV Advanced System One 60 Series	BiPAP autoSV Advanced System One, 60 Series, CA	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP Pro BiFlex w/Htd Humid, BTooth, Sys One 60Srs, AHP	FDA UDI	Class II	Active
Af531	AF531 MASK EE, LEAK 2, with 4 PT Headgear, SU, Large, CN	FDA UDI	Class II	Unknown
EncorePro2	2.23	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP S/T 25 w/Heated Humidifier, IT	FDA UDI	Class II	Active
DreamWear	00	FDA UDI	Class II	Active
DreamMapper App iOS (EMEA)	2.10	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP AVAPS 30 w/Hum w/HTube, No BT, INTL	FDA UDI	Class II	Active
ComfortGel Blue	ComfortGel Blue Nasal Mask w/Headgr, Medium, USA	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Auto A-Flex, System One, 60 Series CN	FDA UDI	Class II	Unknown
Sleepware	3.1	FDA UDI	Class I	Active
DreamStation	DreamStation BiPAP autoSV , No Bluetooth, EU	FDA UDI	Class II	Active
DreamStation BiPAP AVAPS	DreamStation BiPAP AVAPS30 AE w/Humidifier w/WiFi, AU	FDA UDI	Class II	Active
Thermistor NasalOral, Alice PDx, 220	1143241	FDA UDI	Class II	Active
EncoreBasic	2.9	FDA UDI	Class I	Active
Wisp	Wisp Mask, Large, Clear Frame, with Headgear, INTL	FDA UDI	Class II	Active
Pro-Tech	AIRFLOW SENSOR THERMISTOR	FDA UDI	Class II	Active
Trilogy	Trilogy202 Ventilator, Brazil	FDA UDI	Class II	Unknown
REMstar System One 60 Series	REMstar Pro C-Flex+ System One 60 Series LA	FDA UDI	Class II	Unknown
ezRIP	ezRIP, Abdomen, 1.5, 84 inch, Alice	FDA UDI	Class II	Active
DreamWear Gel Pillow	DreamWear Gel Pillows Mask, Medium Frame w/Hgr, JP	FDA UDI	Class II	Unknown
Wisp	1118063	FDA UDI	Class II	Active
DreamStation	DreamStation S/T 30 w/HTD Humid, No BT, AAM, EU	FDA UDI	Class II	Active
DreamStation	01	FDA UDI	Class II	Active
BiPAP A40	CAX3100S12	FDA UDI	Class II	Active
Ac611	AC611 High Flow Nasal Cannula, FEP Connect, Small, INTL	FDA UDI	Class I	Active
GRASS Piezo 1 CH A Kit	GRASS PIEZO 1 EFFORT CT SENSOR	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP Pro with Humidifier, CA	FDA UDI	Class II	Active
REMstar	REMstar Heated Humidifier	FDA UDI	Class II	Active
DreamStation BiPAP AVAPS	DreamStation BiPAP Synchrony AVAPS AAM, with Humidifier	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Plus C Flex, System One 60 Series, Italy	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP AVAPS 30 AAM, EU	FDA UDI	Class II	Active
Ac611	AC611 High Flow Nasal Cannula, FEP Connect, Small, US	FDA UDI	Class I	Active
DreamStation	00	FDA UDI	Class I	Active
DreamStation	DreamStation BiPAP Pro with Humidifier, with WiFi, AHP	FDA UDI	Class II	Unknown
REMstar System One 60 Series	REMstar Auto w/Htd Humid, St Tube, w/Btooth, 60 Srs, CA	FDA UDI	Class II	Active
PRI Cellular Modem	PRI Cellular Modem, JA	FDA UDI	Class I	Unknown
EverFlo	EverFlo, w/Oxygen Percent Indicator, 230V, UltraFill, CH	FDA UDI	Class II	Unknown
REMstar System One 60 Series	REMstar Pro C-Flex+, with Bluetooth, 60 Series, AHP	FDA UDI	Class II	Active
Pico	00	FDA UDI	Class II	Active
Amara	AMARA STARTER KIT, Large	FDA UDI	Class II	Active
Af541	AF541 Mask with SE, Under Nose, w/Capstrap, Size C, JP	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