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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 27 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DreamWear Full | DreamWear Full Mask w/Medium Frame w/Headgear, Global | FDA UDI | Class II | Active |
| BiPAP A40 | DEX3H | FDA UDI | Class II | Active |
| DreamStation | DreamStation Wi-Fi Accessory with Oximetry, CA | FDA UDI | Class I | Active |
| REMstar System One 60 Series | REMstar Pro C-Flex+, w/Humid, with BTooth, 60 Series, CA | FDA UDI | Class II | Active |
| Omnilab Direct | 2.11 | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced with Humidifier, 30cm, 60 Series, LA | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP autoSV, US | FDA UDI | Class II | Active |
| Dorma | Dorma 200 with Humidifier, CA | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Plus C Flex, w/Humid, System One 60 Series, ES | FDA UDI | Class II | Active |
| Care Orchestrator | 1.24 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AutoSV, GB | FDA UDI | Class II | Active |
| REMstar | REMstar Pro C-Flex+, 60 Series, AR | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP w/Cell, JP | FDA UDI | Class II | Unknown |
| DreamStation | 01 | FDA UDI | Class II | Active |
| SimplyGo Mini | SimplyGo Mini, INTL | FDA UDI | Class II | Active |
| Performax | PerformaxMask w/EE Leak2, w/4 PT Hdgr, Large, MPU, CN | FDA UDI | Class II | Unknown |
| ComfortGel Blue | ComfortGel Blue Full Mask, Medium, China | FDA UDI | Class II | Unknown |
| DreamWear Gel Pillow | DreamWear Gel Pillows Mask, Small Frame w/Hgr, JP | FDA UDI | Class II | Unknown |
| Trilogy | U1040005B | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro BlueTooth, US | FDA UDI | Class II | Active |
| zRIP | ALICE 5 ZRIP MODULE | FDA UDI | Class II | Active |
| Af531 | AF531 Mask w/SE, with 4 Point Headgear, Large, USA | FDA UDI | Class II | Active |
| BiPAP A40 | NDX3000H19 | FDA UDI | Class II | Active |
| Alice NightOne | Alice NightOne, Non-Wireless, Brazil | FDA UDI | Class II | Unknown |
| Silver Series Heated Humidifier | Silver Series Heated Humidifier, DE | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| EverFlo | 00 | FDA UDI | Class II | Active |
| DreamWisp | DreamWisp Mask, Med, Sm/Med CONNECTOR, W/Headgear, KR | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Plus C-Flex, w/HT Humid System One 60 Series CN | FDA UDI | Class II | Unknown |
| Amara | AMARA MASK with RS FRAME and Headgear, Petite, CN | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Humidifier, ND | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro BiFlex, with Humidifier, System One 60 Srs,GB | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP with Humidifier, ES | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP with Humidifier, AHP | FDA UDI | Class II | Active |
| EncoreBasic | 2.12 | FDA UDI | Class I | Active |
| REMstar System One 60 Series | REMstar Plus, with Humidifier, 60 Series, CA | FDA UDI | Class II | Unknown |
| BiPAP System One 60 Series | BiPAP Auto BiFlex System One 60 Series,US | FDA UDI | Class II | Unknown |
| Care Orchestrator | 1.25 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP S/T 30 AAM w/Heated Humidifier, EU | FDA UDI | Class II | Active |
| Af541 | AF541 Mask wEE, Leak 2, Under the Nose, 4-PT HEADGR, SIZE C | FDA UDI | Class II | Active |
| Alice PDx | Alice PDx Unit Only, Warranty Exchange, JP | FDA UDI | Class II | Unknown |
| ComfortGel Blue | ComfortGel Blue Nasal Mask w/Headgear, Small, Japan | FDA UDI | Class II | Unknown |
| Alice 6 | ALICE 6 | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class II | Active |
| Contour Deluxe | Contour Deluxe Mask and Headgear, SPU, Small, Korea | FDA UDI | Class II | Unknown |
| Pico | 00 | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| DreamMapper | 2.5 | FDA UDI | Class I | Active |
| DreamStation | DreamStation Auto BiPAP w/WiFi, FR | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP, 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