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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 35 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DreamStation | DreamStation CPAP Pro, ES | FDA UDI | Class II | Active |
| Alice 6 | Alice 6, Base Station System, LDx, Brazil | FDA UDI | Class II | Active |
| DreamMapper Mobile App Android (DMM) | 2.11 | FDA UDI | Class II | Active |
| BiPAP A40 | IAX3000T19 | FDA UDI | Class II | Active |
| Sensor | VELCRO STRAP PLM,SMALL,20CM-8" | FDA UDI | Class II | Active |
| REMstar | REMstar, INTL | FDA UDI | Class II | Active |
| SimplyGo Mini | SimplyGo Mini with Extended Battery, INTL | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro BiFlex, w/Humidifer, System One 60 Series,PT | FDA UDI | Class II | Active |
| A Series | A Series System One Heated Tube Humidifier, INTL | FDA UDI | Class II | Active |
| Sensor | CT2 Effort Sensor Adult, Stardust | FDA UDI | Class II | Active |
| Af541 | AF541 Mask, SE, Under Nose, w/Capstrap, SIZE C | FDA UDI | Class II | Active |
| ComfortGel Blue | ComfortGel Blue Nasal Mask w/o Headgear, Petite, USA | FDA UDI | Class II | Active |
| EncoreAnywhere | EncoreAnywhere - China Instance - 2 | FDA UDI | Class II | Unknown |
| BiPAP A40 | GBX3000H19 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP w/Humidifier, w/H Tube, LA | FDA UDI | Class II | Active |
| Nuance Pro | Nuance Pro Gel Pillows Mask with headgear, USA | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Pro, INTL | FDA UDI | Class II | Active |
| ezRIP | ezRIP Adult Kit, 1.5mm, 84" | FDA UDI | Class II | Active |
| Dorma | Dorma 200, with Humidifier, AU | FDA UDI | Class II | Active |
| Alice 6 | Alice 6, Base Station, LDE, INTL | FDA UDI | Class II | Active |
| Pro-Flow | PRO-FLOW PLUS, NASALORAL, CANNULA ADULT 16" | FDA UDI | Class II | Active |
| Af531 | AF531 Mask w/SE, with CapStrap, Large, USA | FDA UDI | Class II | Active |
| DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 with Humidifier, SP | FDA UDI | Class II | Active |
| Pico | 00 | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro BiFlex, System One 60 Series, GB | FDA UDI | Class II | Active |
| BiPAP A40 | FRX3H | FDA UDI | Class II | Active |
| DreamMapper | 2.7 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Wi-Fi Accessory with Oximetry, AU | FDA UDI | Class I | Active |
| BiPAP System One 60 Series | BiPAP Pro BiFlex+, with BlueTooth, 60 Series, CA | FDA UDI | Class II | Active |
| Performatrak | PERFORMATRAK FULL w CAPSTRAP, MEDIUM | FDA UDI | Class II | Active |
| BiPAP AVAPS | BiPAP AVAPS C Series, 25cm, AU | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP S/T , Postponement | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE, LEAK 1, with CapStrap, Medium, Single Use | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced System One, 60 Series, BR | FDA UDI | Class II | Unknown |
| Af531 | AF531 Mask w/SE, and CapStrap, Medium, Single Use | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP, TR | FDA UDI | Class II | Active |
| Pico | Pico Traditional Nasal Mask without Headgear, Large | FDA UDI | Class II | Active |
| Af541 | AF541 Mask EE, LEAK 1, Under the Nose, CAPSTRAP, INTL, XS | FDA UDI | Class II | Active |
| DreamMapper | 2.24 | FDA UDI | Class II | Active |
| PerformaTrak | PerformaTrak EE Leak1 4PT Headgear, Small, Single Use, China | FDA UDI | Class II | Unknown |
| Amara View | Amara View Mask with Headgear, Large, US | FDA UDI | Class II | Active |
| Alice 6 | Alice 6 Pressure Sensor, US | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Af541 | AF541 Mask with SE, Under the Nose, Capstrap, Size XS, JP | FDA UDI | Class II | Unknown |
| PTAF Lite Kit | PTAF LITE KIT | FDA UDI | Class II | Active |
| ezRIP | ezRIP Adult Kit, Alice 5/LE, 84" | FDA UDI | Class II | Active |
| REMstar | REMstar, INTL | FDA UDI | Class II | Unknown |
| DreamMapper | 2.24 | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Pro C-Flex+, System One 60Series, JP | FDA UDI | Class II | Unknown |
| Amara | M AMARA MASK with RS FRAME and Headgear, Medium, US | 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