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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 38 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| EncoreAnywhere | 2.35 | FDA UDI | Class II | Active |
| EncoreAnywhere | EncoreAnywhere – JP instance - 2 | FDA UDI | Class II | Unknown |
| DreamMapper Web (EMEA) | 2.10 | FDA UDI | Class II | Active |
| DreamStation BiPAP autoSV | DreamStation BiPAP autoSV W/Cell, JP | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Auto BiPAP w/Humid, w/H Tube, AU | FDA UDI | Class II | Active |
| CoughAssist | CoughAssist, E70, BR | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Auto A-Flex, with Humidifier, 60 Series, AHP | FDA UDI | Class II | Active |
| DreamWisp | DreamWisp Mask, Xlarge, Med Connector w/Headgear, Global | FDA UDI | Class II | Active |
| Trilogy | Trilogy Active with PAP Exhalation Circuit, Pediatric | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP S/T30 AAM w/Hum w/HTube, no BT, INTL | FDA UDI | Class II | Active |
| DreamMapper | 2.23 | FDA UDI | Class II | Active |
| Af421 | AF421 Mask with Entrainment Elbow, Leak 1, Small, INTL | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro BiFlex+ w/H Tube Humid, w/BTooth, 60 Srs, CA | FDA UDI | Class II | Active |
| DreamWear Full | DreamWear Full Mask Medium Wide, w/Lareg Frame w/o Headgear, Global | FDA UDI | Class II | Active |
| UltraFill | ULTRAFILL, Switzerland | FDA UDI | Class II | Unknown |
| Nebulizing Elbow | SE Nebulizing Elbow Kit, United States | FDA UDI | Class II | Active |
| EverFlo | EVERFLO QUIET, NON-O2 Percent Indicator, 120V, US, CA | FDA UDI | Class II | Active |
| Amara | 00 | FDA UDI | Class II | Active |
| Performatrak | PERFORMATRAK FULL SE W CAPSTRAP, SMALL | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro, BR | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Plus C Flex, System One 60 Series, ES | FDA UDI | Class II | Active |
| REMstar SE | REMstar SE with Humidifier and SD Slot, LA | FDA UDI | Class II | Unknown |
| DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 AE w/WiFi, AU | FDA UDI | Class II | Active |
| Cbl, Low Lev Out, 1.5mm Conn | CBL | FDA UDI | Class II | Active |
| DreamMapper | 2.8 | FDA UDI | Class II | Active |
| BiPAP ST, C SERIES, FLOW GEN, DOM | 00 | FDA UDI | Class II | Active |
| BiPAP A40 | BiPAP A40 Ventilator, CA | FDA UDI | Class II | Active |
| PerforMax | Entrainment Elbow Starter Kit, Base + PerforMax SU | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP w/Humid w/H Tube, INTL | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP autoSV w/Humidifier, AU | FDA UDI | Class II | Active |
| EncoreAnywhere | 2.33 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro, JP | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro, ND | FDA UDI | Class II | Unknown |
| Af541 | AF541Mask EE, Leak 1, Under the Nose, w/Capstrap, Size C, JP | FDA UDI | Class II | Unknown |
| Pico | Pico Traditional Nasal Mask with Headgear, Large | FDA UDI | Class II | Active |
| Easylife | EasyLife Mask w/Headgear, Small, Japan | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation CPAP Pro w/CPAP Check, w/Humid w/H Tube, CN | FDA UDI | Class II | Unknown |
| A Series | A Series System One Heated Tube Humidifier, US | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced, 30cm, 60 Series, INTL | FDA UDI | Class II | Unknown |
| CoughAssist | CoughAssist E70 Series Oximetry Interface Kit | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro w/Humidifier, w/H Tube, KR | FDA UDI | Class II | Unknown |
| DreamWear Full | DreamWear Full Mask Small, w/Medium Frame w/o Headgear, Global | FDA UDI | Class II | Active |
| DreamMapper | 2.5 | FDA UDI | Class I | Active |
| EncoreAnywhere | 2.37 | FDA UDI | Class II | Active |
| SimplyGo Mini | 00 | FDA UDI | Class II | Active |
| ComfortGel Blue | ComfortGel Blue Nasal Mask w/Headgear, Large, USA | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced, 60 Series, US | FDA UDI | Class II | Unknown |
| Af541 | AF541 Mask EE, Leak 1, Under the Nose, Capstrap, Size C, US | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced w/H Tube Humid, 60 Series, US | FDA UDI | Class II | Unknown |
| System One Humidifier | System One REMstar Heated Humidifier | FDA UDI | Class II | Unknown |
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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