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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 44 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Amara | Amara Mask with SE, Small, with RS Frame and Headgear, INTL | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP with Humidifier, ZA | FDA UDI | Class II | Active |
| Wisp | 1118062 | FDA UDI | Class II | Active |
| Care Orchestrator | 1.6 | FDA UDI | Class II | Active |
| BiPAP A30 | 00 | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced 60 Series, CA | FDA UDI | Class II | Active |
| Alice 6 | Alice 6 LDxS Headbox, INTL and Brazil | FDA UDI | Class II | Active |
| EncoreAnywhere | 2.38 | FDA UDI | Class II | Active |
| DreamWear Full | 1133373UA | FDA UDI | Class II | Active |
| Circuit Tubing | Lightweight Tubing, 6 foot | FDA UDI | Class I | Active |
| EverFlo | EverFlo, w/Oxygen Percentage Indicator, 230V, SA | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Auto CPAP, EU | FDA UDI | Class II | Active |
| Af531 | AF531 MASK, EE, Leak 1, Neb Elbow, w/CapStrap, SU, Large,US | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced w/H Tube Hum, 30cm, 60 Series, CA | FDA UDI | Class II | Active |
| DreamWear Full | DreamWear Full Mask Small, w/Lareg Frame w/Headgear, Global | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| DreamStation Humidifer, Ukraine | 00 | FDA UDI | Class II | Active |
| System One | System One REMstar Heated Humidifier, INTL | FDA UDI | Class II | Active |
| DreamStation Go Auto | DreamStation Go Auto CPAP with Bluetooth, HK | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Auto BiPAP w/Humid w/H Tube, w/WiFi, US | FDA UDI | Class II | Active |
| REMstar | CN157HS | FDA UDI | Class II | Active |
| DreamStation 2 | 00 | FDA UDI | Class II | Active |
| DreamStation BiPAP AVAPS | DreamSt BiPAPAVAPS30, w/Humid MedicAir, RespiComfort | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP w/WiFi, CA | FDA UDI | Class II | Active |
| ComfortGel | 00 | FDA UDI | Class II | Active |
| Alice 6 | LDXN | FDA UDI | Class II | Active |
| Trilogy 100 Ventilator, Japan, Recertified | 00 | FDA UDI | Class I | Active |
| Af811 | AF811 Mask, w/SE, w/Headgear, Small, Single Use | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A-Flex System One 60 Series US | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Auto CPAP w/Humid, w/H Tube, w/Cell, US | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Pro C-Flex+, with Humidifier, 60 Series, AU | FDA UDI | Class II | Active |
| Amara | AMARA MASK with RS FRAME w/o Headgear, Petite, US | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP with Humidifier, AR | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro with C Flex with Humidifier, GB | FDA UDI | Class II | Active |
| Amara View | Amara View Mask with Headgear, Medium | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro w/Humidifier, w/Cell, AHP | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Cellular Modem with Oximetry, PRI, EU | FDA UDI | Class I | Unknown |
| Pro-Flow | PRO-FLOW PLUS NASALORAL CANNULA, PEDIATRICS, 7' | FDA UDI | Class II | Active |
| Amara | AMARA MASK SE with RS FRAME and Headgear, Medium, Japan | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation CPAP Pro w/Humid w/H Tube, AHP | FDA UDI | Class II | Unknown |
| Pico | 00 | FDA UDI | Class II | Active |
| DreamWear Full | 00 | FDA UDI | Class II | Active |
| DreamStation BiPAP autoSV | DreamStation BiPAPautoSV w/Humidifier w/WiFi, US | FDA UDI | Class II | Active |
| Amara | AMARA MASK with RS FRAME AND Headgear, Large, CN | FDA UDI | Class II | Unknown |
| Alice PDx | Alice PDx Core System without Sensors, US | FDA UDI | Class II | Active |
| Trueblue | 00 | FDA UDI | Class II | Active |
| Af541 | AF541 Mask with Standard Elbow, WITH CAPSTRAP, SMALL | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Sensor | Microphone Snore Pocket | FDA UDI | Class II | Active |
| DreamStation | 00606959034303 | 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