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Sign in to claim this brandRespironics, 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
- —
- —
- [email protected]
- Phone
- n/a
- PRRC Contact
- Melissa Rosko
- EUDAMED SRN
- US-MF-000002301
- FDA FEI Number
- 3007220521
- DUNS Number
- 080728314
Catalogue (3774)
Page 36 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Trilogy | Trilogy 202 Ventilator, Canada | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro BiFlex, BlueTooth, System One 60 Series, AHP | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class I | Active |
| DreamStation Go | DreamStation Go Auto CPAP with Bluetooth, ID | FDA UDI | Class II | Active |
| Af541 | AF541 Mask with SE, Under Nose, w/Capstrap, Size B, JP | FDA UDI | Class II | Unknown |
| BiPAP System One 60 Series | BiPAP Auto BiFlex w/H Tube Humid, 60 Series, CA | FDA UDI | Class II | Active |
| M, DreamWear Dm Plw, Med Frm W HGR, Lab | 00 | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Auto, DE | FDA UDI | Class II | Active |
| Care Orchestrator Belgium | 1.13 | FDA UDI | Class II | Active |
| Sensor | Filter 22mm .2micron PVC | FDA UDI | Class II | Active |
| A Series Humidifier | 00 | FDA UDI | Class II | Active |
| DreamMapper | DreamMapper Mobile App iOS EMEA - 2 | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced, 60 Series, DE | FDA UDI | Class II | Unknown |
| DreamMapper | 2.24 | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced, 60 Series, FR | FDA UDI | Class II | Unknown |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Amara Gel | AMARA GEL MASK w/SE, with RS FRAME, Headgear, Petite, JP | FDA UDI | Class II | Unknown |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced w/H Tube Humid, 60 Series, FR | FDA UDI | Class II | Unknown |
| REMstar SE | REMstar SE with Heated Tube, with SD Slot, CA | FDA UDI | Class II | Unknown |
| Dorma 500 | Dorma 500 Auto, CA | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Cellular Modem, EU | FDA UDI | Class I | Unknown |
| Fitlife | FitLife Mask without Headgear, Large, US | FDA UDI | Class II | Active |
| DreamWear Full | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro, US | FDA UDI | Class II | Active |
| Care Orchestrator | Care Orchestrator Essence Software - 2 | FDA UDI | Class II | Active |
| PerformaTrak | PerformaTrak with FEP Procedure Pack, Small, SA | FDA UDI | Class II | Unknown |
| BiPAP System One 60 Series | BiPAP AutoBiFlex w/H Tube Hum, St Tube, BTooth, 60 Srs, CA | FDA UDI | Class II | Active |
| DreamStation BiPAP autoSV | DreamStation BiPAP autoSV w/Humid w/H Tube, w/Cell, CA | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP, EU | FDA UDI | Class II | Active |
| Performax | Performax Mask w/SE, Single Use, XXSmall, China | FDA UDI | Class II | Unknown |
| Pico | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AVAPS30 w/Humidifier, US | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced with Humidifier, 30cm, 60 Series, CA | FDA UDI | Class II | Unknown |
| Af531 | AF531 Mask EE, Leak 1 with CapStrap, Large, Single Use | FDA UDI | Class II | Unknown |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced System One 60 Series, BR | FDA UDI | Class II | Unknown |
| BiPAP | BiPAP A30 EFL, DE | FDA UDI | Class II | Active |
| Comfortfull 2 | COMFORTFULL 2 MASK with SE, SMALL, CHINA | FDA UDI | Class II | Unknown |
| ezRIP | ezRIP, Thorax, 1.5, 84 inch | FDA UDI | Class II | Active |
| DreamWear | 1137440 | FDA UDI | Class II | Active |
| DreamWear | 1137390 | FDA UDI | Class II | Active |
| Af541 | AF541 Mask EE, Leak 1, with 4 Point Headgear, Small | FDA UDI | Class II | Active |
| Alice 6 | Alice 6 LDx Base Station, NA (blue) | FDA UDI | Class II | Active |
| BiPAP A40 | GBX3100H19 | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE, LEAK 1, with CapStrap, Large, Single Use | FDA UDI | Class II | Active |
| ComfortGel Blue | ComfortGel Blue Nasal Mask w/Headgear, Small, USA | FDA UDI | Class II | Active |
| CoughAssist | 00 | FDA UDI | Class II | Active |
| BIPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advnced, 60 Series, 30cm, CA | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Respironics, Inc. Coyol Alajuela · CR FEI 3027553886