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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 39 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DreamMapper | 2.6 | FDA UDI | Class I | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced w/HTD Humid, System One 60 Srs, AHP | FDA UDI | Class II | Active |
| System One | System One Heated Humidifier, JP | FDA UDI | Class II | Unknown |
| SimplyGo Mini | SimplyGo Mini with Standard Battery, BR | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Auto A-Flex, with BlueTooth, 60 Series, CA | FDA UDI | Class II | Active |
| VitalSense | VITALSENSE | FDA UDI | Class II | Active |
| ComfortGel Blue | ComfortGel Blue Full Mask, Small, China | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Pro C-Flex+ System One 60 Series US | FDA UDI | Class II | Unknown |
| BiPAP A30 | BiPAP SOH Ventilator | FDA UDI | Class II | Unknown |
| BiPAP S/T C-Series | BiPAP S/T C Series Core Pack w/Heated Tube, 30cm | FDA UDI | Class II | Unknown |
| BiPAP AVAPS | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP S/T30 AAM, DE | FDA UDI | Class II | Active |
| BiPAP A40 | ESX3100S19 | FDA UDI | Class II | Active |
| BiPAP A40 | BiPAP A40 Ventilator, US | FDA UDI | Class II | Active |
| Nuance Pro | Nuance Pro Gel Pillows Mask, without headgear, Large, USA | FDA UDI | Class II | Active |
| REMstar SE | REMstar SE with Humidifier, with SD Slot, CA | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Auto A-Flex, System One 60 Series, FI | FDA UDI | Class II | Active |
| PerforMax | Performax MPU Mask, Small, with EE & SE, Leak 2, INTL | FDA UDI | Class II | Active |
| Pico | PICO NASAL MASK FITPACK W/Headgear, S/M, L, XL, CHINA | FDA UDI | Class II | Unknown |
| DreamWear | DreamWear Under Nose Mask, Small, Medium Frame, w/o Headgear, Global | FDA UDI | Class II | Active |
| BiPAP ST | 00 | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A-Flex, BR | FDA UDI | Class II | Unknown |
| DreamWear Full | DreamWear Full Mask Large, with Small-Medium Frame, Global | FDA UDI | Class II | Active |
| BiPAP ST | 00 | FDA UDI | Class II | Active |
| Wisp | 1137367 | FDA UDI | Class II | Active |
| EverFlo | EVERFLO 120V w/O2 Percent Indicator, UltraFill, US | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation CPAP Pro, BL | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP w/Humidifier, w/Cell, AHP | FDA UDI | Class II | Unknown |
| Contour Deluxe | Contour Deluxe Mask and Headgear, SPU, Med Large, KR | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation BiPAP S/T 30 with Heated Humidifier, FR | FDA UDI | Class II | Active |
| Easylife | EasyLife Mask w/Headgear, Medium Wide, Japan | FDA UDI | Class II | Unknown |
| ComfortGel Blue | ComfortGel Blue Nasal Mask w/Headgear, Medium, Japan | FDA UDI | Class II | Unknown |
| Af531 | AF531 Mask EE (NE) with CapStrap, Medium, USA | FDA UDI | Class II | Unknown |
| EncoreAnywhere | 2.40 | FDA UDI | Class II | Active |
| BiPAP AVAPS | BiPAP AVAPS C Series, IT | FDA UDI | Class II | Unknown |
| DreamWear | 1137409 | FDA UDI | Class II | Active |
| Af541 | AF541 Discharge Kit, Capstrap LXL | FDA UDI | Class II | Active |
| DreamWisp | DREAMWISP Mask, Small, Sm/Med Connector W/Headgear, KR | FDA UDI | Class II | Unknown |
| ComfortGel Blue | ComfortGel Blue Full Mask with SE, Small, Japan | FDA UDI | Class II | Unknown |
| REMstar | CN457S | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP with Humidifier, INTL | FDA UDI | Class II | Active |
| Sensor | External Flow Sensor w/Cable,Ped/Infant | FDA UDI | Class II | Active |
| A Series Humidifier | 00 | FDA UDI | Class II | Active |
| BiPAP AVAPS | BiPAP AVAPS C Series, 30cm, GB | FDA UDI | Class II | Active |
| Atos | 70 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP with Humidifier, TR | FDA UDI | Class II | Active |
| DreamMapper | DreamMapper Mobile App Android EMEA, - 2 | FDA UDI | Class II | Active |
| A Series | BiPAP A Series, System One Humidifier, JP | FDA UDI | Class II | Unknown |
| EncoreAnywhere | 2.40 | FDA UDI | Class II | Active |
| DreamStation | DreamStation AVAPS 30 AAM w/Hum,no Bluetooth, INTL | 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