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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 52 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DreamStation | DreamStation BiPAP S/T 30, GB | FDA UDI | Class II | Active |
| EncoreAnywhere | 2.37 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP S/T25, no Bluetooth, INTL | FDA UDI | Class II | Active |
| DreamMapper | 2.20 | FDA UDI | Class II | Active |
| Dorma 200 | Dorma 200, CA | FDA UDI | Class II | Active |
| DreamWear | DreamWear Under Nose Mask, Fitpack, NTL | FDA UDI | Class II | Active |
| DreamStation | Dreamstation Expert w/Humid w/H Tube, w/WiFi, CA | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Plus, w/Humid System One 60 Series US | FDA UDI | Class II | Active |
| DreamMapper | 2.23 | FDA UDI | Class II | Active |
| Af541 | AF541 Mask EE, LEAK 1, Under Nose, CAPSTRAP, INTL, SIZE C | FDA UDI | Class II | Active |
| Pico | Pico Traditional Nasal Mask with Headgear, Small-Medium | FDA UDI | Class II | Active |
| Pico | Pico Nasal Mask with Headgear, Small-Medium, China | FDA UDI | Class II | Unknown |
| zRIP | zRIP Durabelt Sum RT Kit, Pediatric | FDA UDI | Class II | Active |
| EverFlo Connect | EverFlo Connect Module, US | FDA UDI | Class I | Active |
| Pn841 | PN841 Mask, JPN, Child Med, SE, Single Use | FDA UDI | Class II | Unknown |
| DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 w/Humidifier w/WiFi, CA | FDA UDI | Class II | Active |
| CoughAssist | Cough Assist E70, FR | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Auto CPAP with Bluetooth, FS Store, GB | FDA UDI | Class II | Active |
| Af531 | AF531 Mask w/SE, and 4 PT Headgear, Medium, Single Use | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Auto, US | FDA UDI | Class II | Active |
| DreamStation | DreamStation AVAPS 25 w/Hum,no Bluetooth, INTL | FDA UDI | Class II | Active |
| CoughAssist | CoughAssist, Facemask, Toddler | FDA UDI | Class II | Active |
| Pico | PICO NASAL MASK W/ RS Headgear, Small-Medium, JP | FDA UDI | Class II | Unknown |
| REMstar | HEATED HUMIDIFIER, INTL | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro BiFlex w/Humid, BlueTooth, Sys One 60Srs, AHP | FDA UDI | Class II | Active |
| Therapy Mask 3100 | Extra Small, Therapy Mask 3100 Silicone | FDA UDI | Class II | Active |
| CoughAssist | CoughAssist 70 SERIES, FOOT PEDAL | FDA UDI | Class II | Active |
| Wisp | 1137361 | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE with 4 point Headgear, Large, USA | FDA UDI | Class II | Active |
| Performatrak | PerformaTrak Full Mask, Small, with CapStrap, Single Use | FDA UDI | Class II | Active |
| Performatrak | PerformaTrak SE Mask w/Headgear, Disp, Large, USA | FDA UDI | Class II | Active |
| Fitlife | FitLife Mask with Headgear, Small, Japan | FDA UDI | Class II | Unknown |
| Dorma | Dorma 500 Auto, AU | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro with Humidifier, ZA | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Auto CPAP with Bluetooth, FS Store, FR | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Auto A-Flex, w/HT Humid System One 60 Series LA | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation CPAP, US | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP S/T30, EE | FDA UDI | Class II | Active |
| PerforMax | PerforMax Mask, Single Patient Use, EE, INTL, Small | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP autoSV, w/Hum w/HTube, no BT, INTL | FDA UDI | Class II | Active |
| Wisp | Wisp Youth Mask, Fabric, with Magnetic Clips, US | FDA UDI | Class II | Active |
| BiPAP ST | 00 | FDA UDI | Class II | Active |
| Amara Gel | AMARA GEL MASK with RS FRAME AND RS Headgear, Petite, US | FDA UDI | Class II | Active |
| Amara Gel | 00 | FDA UDI | Class II | Active |
| Trilogy | U1054260B | FDA UDI | Class II | Active |
| DreamWisp | DreamWisp Mask, Xlarge, MedConnector, wHeadgear, INTL | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class II | Active |
| EncoreAnywhere | 2.43 | FDA UDI | Class II | Active |
| Alice NightOne | Alice NightOne, DuraBelt, Adult | FDA UDI | Class II | Active |
| Alice NightOne | Alice NightOne System, Wireless with Nonin, CN | 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