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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 10 of 76

Device	Model / Reference	Registries	Class	Status
DreamStation	DreamStation BiPAP AVAPS 30 w/HTD Humid, No BT, EU	FDA UDI	Class II	Active
DreamStation Go	JPGH	FDA UDI	Class II	Active
Alice PDx	Alice PDx Sleep Diagnostic System, BR	FDA UDI	Class II	Unknown
PRI Cellular Modem	PRI Cellular Modem with PRI Label, EU	FDA UDI	Class I	Active
DreamStation	00	FDA UDI	Class II	Active
EverFlo	EVERFLO w/Oxygen Percentage Indicator, 230V, HK	FDA UDI	Class II	Unknown
Trilogy	Trilogy200 Ventilator, Australia	FDA UDI	Class II	Active
ComfortGel Blue	ComfortGel Blue Full Mask w/SE, Extra Large, Japan	FDA UDI	Class II	Unknown
ComfortGel	00	FDA UDI	Class II	Active
BiPAP ST	00	FDA UDI	Class II	Active
DreamStation	00	FDA UDI	Class I	Active
Alice NightOne	Alice NightOne, Wireless, Global	FDA UDI	Class II	Active
DreamStation BiPAP ST30	00	FDA UDI	Class II	Active
Nuance Pro	Nuance Pro Gel Pillows Mask, without headgear, Small, USA	FDA UDI	Class II	Active
BiPAP	CN757HS	FDA UDI	Class II	Active
REMstar System (60 Series)	BiPAP Pro BiFlex, System One 60 Series, Latin AmeArica	FDA UDI	Class II	Unknown
DreamStation BiPAP AVAPS	DreamStation BiPAP AVAPS30 w/Humidifier w/Cell, CA	FDA UDI	Class II	Active
Alice 6 SPO2 Module	ALICE 6	FDA UDI	Class II	Active
BiPAP A40	NDX3T	FDA UDI	Class II	Active
DreamMapper App iOS	2.13	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP, KR	FDA UDI	Class II	Unknown
Ac611	AC611 HFNC, FEP Connect Demo Kit, INTL	FDA UDI	Class I	Active
Alice 6	Alice 6 Base Station, LDx, JP	FDA UDI	Class II	Unknown
Af531	AF531 MASK EE, LEAK 2 with 4 PT Headgear, SU, Medium, CN	FDA UDI	Class II	Unknown
REMstar System One 60 Series	REMstar Plus CFlex, System One 60 Series, PT	FDA UDI	Class II	Active
Performatrak	Performatrak SE Mask w/Headgear, Disp, SMALL, KR	FDA UDI	Class II	Unknown
Alice 6	ALICE 6	FDA UDI	Class II	Active
Af541	AF541 Mask EE, Leak 1, with 4 Point Headgear, Medium	FDA UDI	Class II	Active
Af541	00	FDA UDI	Class II	Active
System One 60 Series	00	FDA UDI	Class II	Unknown
Pico	00	FDA UDI	Class II	Active
Pico	00	FDA UDI	Class II	Active
Af541	AF541 Mask EE, LEAK 1, Under Nose, 4-PT HEADGR, INTL, SIZE B	FDA UDI	Class II	Active
BiPAP A40	AUX3000S19	FDA UDI	Class II	Active
System One	System One Heated Humidifier, JP	FDA UDI	Class II	Unknown
DreamStation	DreamStation Auto BiPAP w/Cell, US	FDA UDI	Class II	Active
Actiwatch 2	Actiwatch 2 Dock Sub Assembly	FDA UDI	Class II	Active
Sensor	External Flow Sensor, Adult/Ped	FDA UDI	Class II	Active
Af541	AF541 Mask, EE, LEAK 2, WITH CAPSTRAP, X-LARGE	FDA UDI	Class II	Active
PerformaTrak	PerformaTrak EE Mask w/4 PT Headgear, SU, Large, CN	FDA UDI	Class II	Unknown
DreamWear	1137431	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP Auto, CN	FDA UDI	Class II	Unknown
Dorma 500	00	FDA UDI	Class II	Active
Af541	AF541 Mask, EE, LEAK 2, WITH 4-POINT HEADGEAR, X-LARGE	FDA UDI	Class II	Active
Pico	00	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP Pro w/Cell, JP	FDA UDI	Class II	Unknown
DreamStation	DreamStation Auto CPAP with Humidifier, Latin America	FDA UDI	Class II	Active
EverFlo	EVERFLO, 120V, UltraFill, US	FDA UDI	Class II	Unknown
Af541	AF541 Discharge Kit, LXL 4 Point Headgear	FDA UDI	Class II	Active
Pn841	PN841 Mask, INTL, Child Large, Leak 3, ASM	EUDAMEDFDA 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