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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 9 of 76

Device	Model / Reference	Registries	Class	Status
Af421	AF421 Mask with Standard Elbow, Small, Global	FDA UDI	Class II	Active
DreamStation	DreamStation Wi-Fi Accessory with Oximetry, CA	FDA UDI	Class I	Active
Performatrak	PERFORMATRAK FULL FACE MASK W CAPSTRAP,INT, MEDIUM	FDA UDI	Class II	Active
Nebulizing Elbow	Standard Elbow, Nebulizing Elbow Kit	FDA UDI	Class II	Active
Easylife	EasyLife Mask w/Headgear, Petite, International	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP Auto BiFlex, System One 60 Series, CN	FDA UDI	Class II	Unknown
Sensor	Piezo 1 CH A/P 1.5" Kit	FDA UDI	Class II	Active
BIPAP autoSV Advanced System One 60 Series	BiPAP autoSV Advanced, 60 Series, 30cm, FR	FDA UDI	Class II	Unknown
CoughAssist	CoughAssist 70 Series Circuit, Infant, 6ft	FDA UDI	Class II	Active
REMstar	REMstar Auto A-Flex, 60 Series, AR	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP Pro with Humidifier, CN	FDA UDI	Class II	Unknown
REMstar System One 60 Series	REMstar Pro C-Flex+, w/Humid, System One 60Series, JP	FDA UDI	Class II	Unknown
DreamStation	DreamStation Auto CPAP w/Humidifier, w/Cell, CA	FDA UDI	Class II	Active
EncoreAnywhere	2.36	FDA UDI	Class II	Active
DreamWisp	DreamWisp Mask, Petite, Med Connector w/Headgear, CEE	FDA UDI	Class II	Active
DreamWear	00	FDA UDI	Class II	Active
PerforMax	Performax Mask w/SE, Single Use, XSmall, KR	FDA UDI	Class II	Unknown
EncoreAnywhere	2.43	FDA UDI	Class II	Active
DreamMapper	2.23	FDA UDI	Class II	Active
DreamWear	00	FDA UDI	Class II	Active
BiPAP autoSV Advanced System One 60 Series	BiPAP autoSV Advanced 60 Series, LA	FDA UDI	Class II	Active
SimplyGo Mini	SimplyGo Mini, BR	FDA UDI	Class II	Unknown
DreamStation	DreamStation Auto BiPAP with Humidifier, AU	FDA UDI	Class II	Active
DreamStation	00	FDA UDI	Class II	Active
BiPAP A40	EEX3000S19	FDA UDI	Class II	Active
DreamMapper Web (EMEA)	2.16	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP with Humidifier, EE	FDA UDI	Class II	Active
DreamStation	DreamStation Auto CPAP, IT	FDA UDI	Class II	Active
Performax	Performax Mask w/SE, Large, Single Use, China	FDA UDI	Class II	Unknown
DreamStation	DreamStation BiPAP autoSV w/Humid, no Bluetooth, INTL	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP Auto BiFlex w/Humid, BTooth, SystemOne 60Srs, AHP	FDA UDI	Class II	Active
DreamWear Full	DreamWear Full Mask, S, M Frame with Headgear, USA	FDA UDI	Class II	Active
DreamStation	DreamStation Auto BiPAP w/Humid, w/H Tube, w/Cell, AU	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP AVAPS30 AAM BL	FDA UDI	Class II	Active
DreamWear	00	FDA UDI	Class II	Active
BiPAP AVAPS	BiPAP AVAPS C Series Core Pack, AHP	FDA UDI	Class II	Active
zRIP	zRIP Durabelt Kit, Adult, PDx	FDA UDI	Class II	Active
REMstar SE	REMstar SE with SD Slot, CA	FDA UDI	Class II	Unknown
Alice 6	Alice 6 Base Station, LDx with Masimo, INTL	FDA UDI	Class II	Active
Af811	AF811 with FEP Procedure Pack, Large, SA	FDA UDI	Class II	Unknown
Af811	AF811 Mask with Headgear, Small, Single Use	FDA UDI	Class II	Active
Performax	Performax Mask w/EE Leak 2, Large, Single Use, China	FDA UDI	Class II	Unknown
DreamStation	DreamStation BiPAP AVAPS 30, IT	FDA UDI	Class II	Active
Af531	AF531 Mask EE with 4 PT Headgear, Small, USA	FDA UDI	Class II	Active
DreamStation	DreamStation AVAPS 30 AAM ND	FDA UDI	Class II	Active
DreamWear Dm Plw, Setup Pack	00	FDA UDI	Class II	Active
Nuance	Nuance Gel Pillows Mask with Headgear, USA	FDA UDI	Class II	Active
ComfortGel	ComfortGel Blue Full Mask, Extra Large, China	FDA UDI	Class II	Unknown
Stardust	STARDUST	FDA UDI	Class II	Active
DreamWear	00	FDA UDI	Class II	Active

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FDA Establishments (1)

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Respironics, Inc. Coyol Alajuela · CR FEI 3027553886