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 64 of 76

Device	Model / Reference	Registries	Class	Status
REMstar Auto A-Flex, 60 Series, INTL	IN561S	EUDAMEDFDA UDI	Class IIa	Active
Roll Stand, Transcutaneous CO2 Connection Cable	1146885	EUDAMEDFDA UDI	Class I	Active
Alice PDx ECG Yoke, INTL	1040810	EUDAMEDFDA UDI	Class IIa	Active
Piezo 1 Ch Pediatric Kit	P1462R	EUDAMEDFDA UDI	Class I	Active
Trilogy 200 Ventilator, Germany-Recert	U1032802	EUDAMEDFDA UDI	Class IIb	Active
Trilogy 200 Ventilator, Intl-Recert	U1032800	EUDAMEDFDA UDI	Class IIb	Active
Recert, Alice NightOne Intl Wireless	U1114801	EUDAMED	Class IIa	Active
Trilogy 202 Ventilator Germany	1040003	EUDAMEDFDA UDI	Class IIb	Active
Alice NightOne Wireless, Warranty , INTL	1114802	EUDAMEDFDA UDI	Class IIa	Active
Contour Deluxe Su W/Headgear, M/L, Int – 10 Pk	1016696	EUDAMED	Class IIa	Active
InnoSpire Go EU1/ROW	1126593	EUDAMEDFDA UDI	Class IIa	Active
REMstar Pro C-Flex+, 60 Series, INTL	IN461S	EUDAMEDFDA UDI	Class IIa	Active
Recert Trilogy 100 Ventilator, INTl - BT	U1054096B	EUDAMEDFDA UDI	Class IIb	Active
BiPAP Auto BiFlex, w/Humid System One 60 Series INT	IN761HS	EUDAMEDFDA UDI	Class IIa	Active
Li Ion Battery, Ventilation, International	1126944	EUDAMEDFDA UDI	Class I	Active
BiPAP Pro BiFlex System One 60 Series INT	IN661S	EUDAMEDFDA UDI	Class IIa	Active
AW CT Roche BP29937 Pkg Scorer	1131667	EUDAMED	Class IIa	Active
Alice PDx Unit Only, Warranty Exchange, INTL	1057624	EUDAMEDFDA UDI	Class IIa	Active
SPRS-2 Roll Stand, H-104 cm, EV300 Mount	1141766	EUDAMED	Class I	Active
DreamStation Roll Stand	1131859	EUDAMED	Class I	Active
Litetouch Small Mask	1082714	EUDAMEDFDA UDI	Class I	Active
Trilogy Evo O2, Eastern Europe	EE2100X15B	EUDAMEDFDA UDI	Class IIb	Active
REMstar Auto A-Flex, w/H Tube Humid, 60 Series, INTL	IN561TS	EUDAMEDFDA UDI	Class IIa	Active
Trilogy EV300, Great Britain	GB2200X15B	EUDAMED	Class IIb	Active
BiPAP A30, Silver Series- RENTAL	R1116155	EUDAMED	Class IIb	Active
Trilogy Evo O2, Nordics	ND2100X15B	EUDAMEDFDA UDI	Class IIb	Active
Recert, Alice NightOne Intl	U1114803	EUDAMED	Class IIa	Active
BiPAP autoSV ADV, w/Humid 60 Series, 30cm, INTL	IN961XHS	EUDAMEDFDA UDI	Class IIb	Active
Premium Chin Strap	1012911	EUDAMEDFDA UDI	Class I	Active
BiPAP A40 Ventilator Private Label, INTL	1111170	EUDAMEDFDA UDI	Class IIb	Active
zRIP Cable Abdomen, QDC	P1176	EUDAMEDFDA UDI	Class I	Active
Trilogy Evo, O2, International	IN2100X15B	EUDAMED	Class IIb	Active
Trilogy 100 Ventilator, Germany	1054097	EUDAMED	Class IIb	Active
Trilogy EV300, INT w/ OBM	FX2200X15B	EUDAMEDFDA UDI	Class IIb	Active
System One 60 Series Shielded DC Cord	1097568	EUDAMED	Class I	Active
AW CT Sanifit SNFCT2020-07 Scorer	1148695	EUDAMED	Class IIa	Active
AW CT Insmed INS 416 Pkg Scorer	1149188	EUDAMED	Class IIa	Active
AW CT Bayer 20887 Site	1148541	EUDAMED	Class IIa	Active
REMstar Pro C-Flex+, System One 60 Series, Italy	IT461S	EUDAMEDFDA UDI	Class IIa	Active
AW CT Sanifit SNFCT2020-07 Site	1148696	EUDAMED	Class IIa	Active
Reduced Size Premium Headgear, International	1059257	EUDAMEDFDA UDI	Class I	Active
BiPAP A30, Medicair Respicomfort	1111144M	EUDAMEDFDA UDI	Class IIb	Active
Actical-Recertified	U1081737	EUDAMED	Class IIa	Active
Trilogy Evo O2, Italy	IT2100X21B	EUDAMEDFDA UDI	Class IIb	Active
BiPAP autoSV ADV SYS ONE w/Humid, 60 Series INTL	IN961HS	EUDAMEDFDA UDI	Class IIb	Active
BiPAP Auto BiFlex, System One 60 Series, GB	GB761S	EUDAMEDFDA UDI	Class IIa	Active
Small Comfort Classic with Headgear - Iberia	1007967	EUDAMEDFDA UDI	Class IIa	Active
PAP Li Ion Battery Kit, Sleep, Intl–Rental	R1126942	EUDAMED	Class I	Active
Adult Mask / Large	HS81311-010	EUDAMEDFDA UDI	Class I	Active
DreamWear Gel Pillows Mask, L, M Frame w/o Headgear, Global	1125008	EUDAMEDFDA UDI	Class IIa	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