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: 3002797442
DUNS Number: —

Catalogue (84)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
PN841, INTL, Child Large, Leak 3, 5 Pack	1130581	EUDAMED	Class IIa	Active
BiPAP A40 Pro Titration Rental Program IN	RINX3100S19	EUDAMED	Class IIb	Active
L DreamWear Under the Nose Nasal, Lg Frame W/HGR, GBL	1116692	EUDAMEDFDA UDI	Class IIa	Active
FitLife Mask with Headgear, w/SE, Small, INTL	1061711	EUDAMEDFDA UDI	Class IIa	Active
DreamWear Under the Nose Nasal, Med Frame W/HGR, GBL	1116700	EUDAMEDFDA UDI	Class IIa	Active
Amara Mask W/ Rs Frame And Headgear, Medium, Intl	1090225	EUDAMEDFDA UDI	Class IIa	Active
Roll Stand, BiPAP A-series	1098538	EUDAMED	Class I	Active
Trilogy EV300, France	FR2200X14B	EUDAMED	Class IIb	Active
BiPAP Auto BiFlex, w/HT Humid System One 60 Series, INTL	IN761TS	EUDAMEDFDA UDI	Class IIa	Active
S Comfortgel Blue Se Nasal Mask W/Hgr, Intl	1070070	EUDAMEDFDA UDI	Class IIa	Active
L Fitlife Mask Ee W/Hgr Int	1060804	EUDAMEDFDA UDI	Class IIa	Active
BiPAP autoSV ADV SYS ONE w/HT Humid, 60 Series, GER	DE962TS	EUDAMEDFDA UDI	Class IIb	Active
DreamStation 2 CPAP AdvancedHumid/Cell/BT, EU	EUX420H15C	EUDAMED	Class IIa	Active
DreamStation 2 CPAP Advanced Humid/Cell/BT, ES	ESX420H15C	EUDAMED	Class IIa	Active
MW, DreamWear Under the Nose Nasal, Lg Frame W/O HGR, GBL	1116718	EUDAMEDFDA UDI	Class IIa	Active
SE Nebulizing Elbow Kit, 5 Pack	1076754	EUDAMED	Class IIa	Active
L, DreamWear Silicone Pillows, Large Frame with Headgear, Asian Pacific	1146450AP	EUDAMEDFDA UDI	Class IIa	Active
Valve, Exh, Low Pf Iso Tee W/ Pap, Ce	C06724	EUDAMED	Class IIa	Active
Wisp Mask, Clear Frame, W/ Hdgr, Intl	1094060	EUDAMEDFDA UDI	Class IIa	Active
FEP Circuit S/A w/Filter – INTL	1065834	EUDAMEDFDA UDI	Class IIa	Active
Amara Gel Mask With Rs Frame And Headgear Intl, Petite	1090420	EUDAMEDFDA UDI	Class IIa	Active
DreamStation 2 CPAP Advanced Humid/BT only, EU	EUX420H15	EUDAMED	Class IIa	Active
Bronchoscopy Elbow (BE) RP Kit, 5 Pack	1072652	EUDAMED	Class IIa	Active
Trilogy 200 Ventilator, Italy- BT	IT1032800B	EUDAMEDFDA UDI	Class IIb	Active
EE Nebulizing Elbow Kit, 5 Pack	1072650	EUDAMED	Class IIa	Active
M, DreamWear Silicone Pillows, Medium Frame with Headgear, Asian Pacific	1146415AP	EUDAMEDFDA UDI	Class IIa	Active
Trilogy Active PAP Tube Port Adapter	1061398	EUDAMEDFDA UDI	Class IIa	Active
Medium pediatric mask with 22mm connector for use with Philips Respironics valved holding chambers, Silicone mask 18 months - 6 years	HS81210EU-001	EUDAMEDFDA UDI	Class I	Active
Valve, Exh, Iso Tee W/Pap Ce-Eu	1003687	EUDAMED	Class IIa	Active
M DreamWear Under the Nose Nasal, Lg Frame W/HGR, GBL	1116691	EUDAMEDFDA UDI	Class IIa	Active
S PerforMax MPU INTL w/EE Leak 2 & SE, Plus 4 HG	1052553	EUDAMEDFDA UDI	Class IIa	Active
Amara View Mask without Headgear, Small	1090612	EUDAMEDFDA UDI	Class IIa	Active
LifeVentEVO2	SP2100X26B	EUDAMEDFDA UDI	Class IIb	Active
AW CT Angelini 152PO17433 Pkg Scorer	1140687	EUDAMED	Class IIa	Active
A40 Pro/EFL Detachable Battery Module, Rental	R3000DBM	EUDAMED	Class I	Active
DreamStation 2 CPAP Advanced Humid/Cell/BT, GB	GBX420H15C	EUDAMED	Class IIa	Active
Detachable Battery Module, USA/INTL Rental	R1096770	EUDAMED	Class I	Active
BiPAP A40 In-Use Case	1098513	EUDAMEDFDA UDI	Class I	Active
S Fitlife Mask Ee W/Hgr Int	1060803	EUDAMEDFDA UDI	Class IIa	Active
DreamStation 2 Auto CPAP Advanced w/ Humidifier/Cell/Bluetooth®, EE	EEX520H15C	EUDAMED	Class IIa	Active
WISP MASK, FABRIC FRAME, with Headgear, International	1094061	EUDAMEDFDA UDI	Class IIa	Active
S Amara Gel Mask Se W/Rs Frame And Rs Hgr Int	1090431	EUDAMEDFDA UDI	Class IIa	Active
DreamStation 2 Auto CPAP w/ Humidifier/Cell/Bluetooth, EE	EEX510H15C	EUDAMED	Class IIa	Active
L, DreamWear Under the Nose Nasal, Med Frame W/O HGR, GBL	1116707	EUDAMEDFDA UDI	Class IIa	Active
Trilogy Active Flow Exhalation Circuit Adult	1068837	EUDAMEDFDA UDI	Class IIa	Active
Trilogy 100 Ventilator, Germany-BT-RENT	R1054097B	EUDAMEDFDA UDI	Class IIb	Active
DreamStation Go Battery Pack	1133281	EUDAMED	Class I	Active
2” Miniature Flextube - 22mm x 15mm	1006043	EUDAMEDFDA UDI	Class IIa	Active
Deluxe Chin Strap, International	1006085	EUDAMED	Class I	Active
DreamStation 2 Auto CPAP Advanced Humid/Cell/BT, IT	ITX520H15C	EUDAMED	Class IIa	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.