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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 59 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| REMstar System One 60 Series | REMstar Pro C-Flex+, w/H Tube Humid, w/Btooth, 60 Srs, CA | FDA UDI | Class II | Active |
| Ac611 | 00 | FDA UDI | Class I | Active |
| SimplyGo Mini | SimplyGo Mini, Standard Battery, Argentina | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AutoSV, FR | FDA UDI | Class II | Active |
| Alice 6 | LDXS | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP autoSV w/Humidifier, BL | FDA UDI | Class II | Active |
| DreamWear | DreamWear Under Nose Mask, M Frame w/Headgear, CN | FDA UDI | Class II | Unknown |
| EncoreAnywhere | 2.41 | FDA UDI | Class II | Active |
| Ac611 | AC611 High Flow Nasal Cannula, 22mm (M), Large, INTL | FDA UDI | Class I | Active |
| Alice 6 | Alice 6, Base Station, LDE, Brazil | FDA UDI | Class II | Active |
| Fitlife | FitLife Mask with Headgear, Large, Japan | FDA UDI | Class II | Unknown |
| DreamWear Full | DreamWear Full Mask Small with Small-Medium Frame, INTL | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP w/Humid w/Heated Tube, CN | FDA UDI | Class II | Unknown |
| Easylife | 00 | FDA UDI | Class II | Active |
| Nuance | Nuance Gel Pillows Mask, without headgear, USA | FDA UDI | Class II | Unknown |
| VitalSense | VITALSENSE | FDA UDI | Class II | Active |
| Pro-Tech | PRO-FLOW | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go CPAP with Bluetooth, US | FDA UDI | Class II | Active |
| OmniLab Advanced Plus | BiPAP Hybrid A30 Ventilator, SpO2, JP | FDA UDI | Class II | Unknown |
| Comfortfull 2 | COMFORTFULL 2 Mask with Headgear, Large, China | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Pro C-Flex+, w/Humid System One 60 Series LA | FDA UDI | Class II | Unknown |
| Dorma 500 | Dorma 500 Auto, DE | FDA UDI | Class II | Unknown |
| DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 w/WiFi, CA | FDA UDI | Class II | Active |
| Af531 | AF531 Mask w/SE, and CapStrap, Small, Single Use | FDA UDI | Class II | Active |
| DreamMapper | 2.8 | FDA UDI | Class II | Active |
| BiPAP AVAPS, C SERIES, FLOW GEN, DOM | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AVAPS30 AAM, EE | FDA UDI | Class II | Active |
| Dorma | Dorma 200, with Humidifier, LA | FDA UDI | Class II | Unknown |
| Af531 | AF531 Mask EE (NE) with CapStrap, Small, USA | FDA UDI | Class II | Active |
| Wisp | Wisp Mask, Clear Frame, with Headgear, w/SE, INTL | FDA UDI | Class II | Active |
| PerforMax | Performax Mask w/EE Leak 2 & SE, MPU, Large, USA | FDA UDI | Class II | Active |
| BiPAP A40 | FRX3100S14 | FDA UDI | Class II | Active |
| Fitlife | FitLife Mask with Headgear, Small, US | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro BiFlex, System One 60 Series, NO | FDA UDI | Class II | Active |
| DreamStation BiPAP S/T | DreamStation BiPAP S/T30 with Humidifier, IT | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP, IT | FDA UDI | Class II | Active |
| System One, 50 Series | 00 | FDA UDI | Class II | Active |
| DreamMapper Web (DM) | 2.14 | FDA UDI | Class II | Active |
| Sensor | GRASS SPI DC | FDA UDI | Class II | Active |
| Af811 | AF811 Mask with Headgear, Medium, Single Use | FDA UDI | Class II | Active |
| BiPAP S/T 20 60 Series | BiPAP S/T 20 60 Series | FDA UDI | Class II | Unknown |
| OmniLab Advanced Plus | BiPAP Hybrid A30 Ventilator, Japan | FDA UDI | Class II | Unknown |
| DreamWear Full | 00 | FDA UDI | Class II | Active |
| Af421 | AF421 Mask with Entrainment Elbow, Leak 2, XLarge, Global | FDA UDI | Class II | Active |
| Af811 | AF811 Mask with Headgear, Medium, Single Use | FDA UDI | Class II | Active |
| Sensor | External Flow Sensor w/Cable, Adult/Ped | FDA UDI | Class II | Active |
| Alice 4 | BODY POSITION SENSOR, ALICE 4 | FDA UDI | Class II | Active |
| Care Orchestrator Essence Software | 3.2 | FDA UDI | Class II | Active |
| DreamMapper Mobile App Android (APAC) | 2.9 | FDA UDI | Class II | Active |
| OmniLab Direct | 2.11 | 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