Is this your brand? Sign in to claim ownership.

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 63 of 76

Device	Model / Reference	Registries	Class	Status
DreamStation	DreamStation CPAP, ZA	FDA UDI	Class II	Active
EncoreAnywhere	2.39	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP Pro with Humidifier, AR	FDA UDI	Class II	Active
Performatrak	PERFORMATRAK SE REUSABLE PACK, MEDIUM, KOREA	FDA UDI	Class II	Unknown
Af531	AF531 Mask EE, Leak 2, w/CapStrap, Large, SU	FDA UDI	Class II	Active
DreamWear Full	DreamWear Full Mask Large, w/Large Frame w/Headgear, Global	FDA UDI	Class II	Active
EverFlo	EVERFLO w/Oxygen Percentage Indicator, 230V, CN	FDA UDI	Class II	Unknown
EverFlo	EVERFLO NON-O2 Percentage Indicator, 120V, US,CA	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP with Humidifier, CA	FDA UDI	Class II	Active
Amara	AMARA MASK w/SE, with RS FRAME, RS Headgear, Small, CN	FDA UDI	Class II	Unknown
Amara View	Amara View Mask with Headgear, Large	FDA UDI	Class II	Active
System One	100240B	FDA UDI	Class I	Active
BiPAP S/T C-Series	BiPAP S/T C Series Core Pack, 30cm, US	FDA UDI	Class II	Unknown
Sensor	CT2 A Chest Pocket	FDA UDI	Class II	Active
Amara	00	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP AVAPS30 AAM, FR	FDA UDI	Class II	Active
CoughAssist	CoughAssist E70 INTL, IT	FDA UDI	Class II	Active
DreamStation BiPAP AVAPS	DreamStation BiPAP AVAPS30 AAM, w/ Humidifier, Linde EOLUS	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP Pro with Humidifier, ND	FDA UDI	Class II	Unknown
DreamWear Dm Plw, FitPack, GBL	00	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP S/T30 w/Humidifier, TR	FDA UDI	Class II	Active
Af811	AF811 Mask w/SE, with Headgear, Medium, Single Use	FDA UDI	Class II	Active
CoughAssist	CoughAssist 70 Series Circuit, Adult Medium, 6ft	FDA UDI	Class II	Active
Af531	AF531 Mask w/SE, w/4 PT Headgear, Small, USA	FDA UDI	Class II	Active
DreamMapper	2.17	FDA UDI	Class II	Active
DreamStation 2	DreamStation 2 Auto CPAP with Humidifier, Cellular, Bluetooth for BL	FDA UDI	Class II	Active
Performatrak	Performatrak Mask w/SE and Headgr, Large, Disp, INTL	FDA UDI	Class II	Active
DreamMapper Web China Instance v 2.11	2.11	FDA UDI	Class II	Active
BiPAP A40	BLX3T	FDA UDI	Class II	Active
Sensor	AFS 1 CH.ADULT CANN.STYLE AL4	FDA UDI	Class II	Active
Adult Vel.strap Kit 1.5", Size 1	VELCRO STRAP	FDA UDI	Class II	Active
DreamStation	01	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP Pro with Humidifier, IT	FDA UDI	Class II	Unknown
Af531	AF531 Mask EE with CapStrap, Small, USA	FDA UDI	Class II	Active
Easylife	EasyLife Mask w/Headgear, Medium, International	FDA UDI	Class II	Active
Pn841	PN841 Mask, JPN, Child Small, SE, ASM	FDA UDI	Class II	Active
DreamWear	DreamWear Under Nose Mask, S, L Frame w/o Headgr, Global	FDA UDI	Class II	Active
DreamMapper	2.8	FDA UDI	Class II	Active
BiPAP A40	IAX3000S19	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP autoSV w/Humid w/H Tube, CA	FDA UDI	Class II	Active
Trilogy Evo, O2, Japan	JP2100X16B	FDA UDI	Class II	Active
Garbin Ventilator - Bluetooth	1058180B	EUDAMED	Class IIb	Active
Trilogy 200 Ventilator, AERIS 200-BT	1125564B	EUDAMEDFDA UDI	Class IIb	Active
Profile Lite 2 Mask with Headgear, Small, Italy	1132183	EUDAMEDFDA UDI	Class IIa	Active
BiPap Vision Disposable Circuit, Single	582072	EUDAMEDFDA UDI	Class IIa	Active
"Alice PDx ECG Yoke Cable, Intl "	RBR1040810	EUDAMED	Class IIa	Active
Profile Lite 2 SE with Headgear, Medium, Italy	1132186	EUDAMEDFDA UDI	Class IIa	Active
NK Piezo Sensor	P1496	EUDAMEDFDA UDI	Class I	Active
Trilogy Evo O2, Iberia	ES2100X15B	EUDAMEDFDA UDI	Class IIb	Active
Portable electric ventilator	1116155	EUDAMEDFDA UDI	Class IIb	Active

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Respironics, Inc. Coyol Alajuela · CR FEI 3027553886