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 57 of 76

Device	Model / Reference	Registries	Class	Status
DreamStation BiPAP AVAPS	DreamStation BiPAP Synchrony AVAPS AAM	FDA UDI	Class II	Active
EverFlo	EVERFLO QUIET, 120V, UltraFill, US	FDA UDI	Class II	Unknown
Amara View	00	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP Pro, TR	FDA UDI	Class II	Active
DreamStation	DreamStation Auto BiPAP, ES	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP Auto, JP	FDA UDI	Class II	Unknown
Af541	AF541, Bronchoscopy Elbow, Click Style	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Pro C Flex+, w/Humid, System One 60 Srs, ND	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Pro C-Flex+, System One 60 Series, PT	FDA UDI	Class II	Active
Af531	AF531 Mask EE, LEAK 1, with 4 PT Headgear, Small, Single Use	FDA UDI	Class II	Active
DreamWear Full	DreamWear Full Mask Large w/Large Frame w/o Headgear, Global	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP Pro BiFlex with Humidifier, System One 60 Srs, AHP	FDA UDI	Class II	Active
ComfortGel Blue	ComfortGel Blue Nasal Mask w/Headgear, Small, USA	FDA UDI	Class II	Active
Sensor	PEDIATRIC PIEZO SENSOR STRAP 1"	FDA UDI	Class II	Active
DreamStation	DreamStation Heated Humidifier, ES Praxair	FDA UDI	Class II	Active
Care Orchestrator	1.3	FDA UDI	Class II	Active
DreamStation BiPAP AVAPS	DreamStation BiPAP AVAPS30 AE w/Humd w/H Tube w/Cell, AU	FDA UDI	Class II	Active
Replacement Part 24 Inch Grey Tubing	00	FDA UDI	Class II	Active
DreamStation	DreamStation Auto CPAP w/Humidifier, w/WiFi, CA	FDA UDI	Class II	Active
BiPAP A40	ESX3000H19	FDA UDI	Class II	Active
Amara View	Amara View Mask w/SE, with Headgear, Small, JP	FDA UDI	Class II	Active
Fitlife	FitLife with Lab Headgear Lab Mask, Small, US	FDA UDI	Class II	Active
Af531	AF531 Mask EE, Leak 1 with CapStrap, Medium, SU	FDA UDI	Class II	Unknown
DreamStation	DreamStation CPAP Pro, ZA	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP w/Humidifier, w/Heated Tube, INTL	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Auto P-Flex, FR	FDA UDI	Class II	Active
Performax	Performax Mask w/EE Leak 2, 4 PT Headgear, MPU, Small, China	FDA UDI	Class II	Unknown
Af531	AF531 Mask EE (NE) with 4 point Headgear, Medium, USA	FDA UDI	Class II	Active
zRIP	zRIP WIRESET, ALICE PDx	FDA UDI	Class II	Active
EverFlo	EVERFLO w/Oxygen Percentage Indicator, 230V, ZA	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP, IT	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP Pro w/Cell, AHP	FDA UDI	Class II	Active
A Series	A Series Humidifer, INTL	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP Pro, INTL	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Auto A-Flex, w/H Tube Humid, 60 Series, CA	FDA UDI	Class II	Active
Sensor	Airflow Sensor Thermocouple, RoHS Adult Disp	FDA UDI	Class II	Active
Wisp	Wisp Mask, Fabric Frame, without Headgear, XL, US	FDA UDI	Class II	Active
BiPAP AVAPS	BiPAP AVAPS C Series Sapio Belife	FDA UDI	Class II	Active
Pro-Flow	PRO-FLOW NASAL CANNULA, ADULT 1.1M	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Auto A-Flex w/ Humid, BTOOTH Sys One 60 Srs, US	FDA UDI	Class II	Active
Amara Gel	00	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP S/T30 AAM w/Humidifier, TR	FDA UDI	Class II	Active
OmniLab Advanced Plus	OmniLab Advanced Plus, CN	FDA UDI	Class II	Unknown
Care Orchestrator Japan	1.12	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP S/T 25, DE	FDA UDI	Class II	Active
DreamWisp	DreamWisp Mask, Medium, Med Connector w/Headgear, RU/C Asia	FDA UDI	Class II	Active
DreamStation	DreamStation Auto BiPAP w/Cell, JP	FDA UDI	Class II	Unknown
DreamStation	DreamStation BiPAP S/T 25 w/ HTD Humid, No BT, EU	FDA UDI	Class II	Active
SimplyGo Mini	SimplyGo Mini with Extended Battery, KR	FDA UDI	Class II	Unknown
BiPAP A30	BiPAP A30 Ventilator, BR	FDA UDI	Class II	Unknown

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