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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 40 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DreamStation Go | DSGH | FDA UDI | Class II | Active |
| Trilogy | RSL1054260B | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class I | Active |
| DreamStation | DreamStation CPAP Pro with C-Flex, GB | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro with Humidifier, INTL | FDA UDI | Class II | Active |
| Dorma 500 | Dorma 500 Auto with Humidifier, CA | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class I | Active |
| REMstar System One 60 Series | REMstar Auto A-Flex w/Humid System One 60Series JP | FDA UDI | Class II | Unknown |
| BiPAP S/T C-Series | BiPAP S/T C Series, 25CM, ES | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Care Orchestrator Essence | 2.0 | FDA UDI | Class II | Active |
| Nuance | Nuance Gel Pillows Mask, without headgear, Large, USA | FDA UDI | Class II | Unknown |
| PerformaTrak | PerformaTrak SE Leak1 4PT Headgear, Small, Single Use, China | FDA UDI | Class II | Unknown |
| DreamWisp | DreamWisp Mask, Large, Med Connector w/o Headgear, Global | FDA UDI | Class II | Active |
| Af541 | AF541Mask EE, Leak 1, Under the Nose, w/Capstrap, Size B, JP | FDA UDI | Class II | Unknown |
| BiPAP System One 60 Series | BiPAP Pro Bi-Flex w/ Humid, System One 60 Series, CN | FDA UDI | Class II | Unknown |
| Pico | 00 | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A-Flex, w/Humid System One 60 Series LA | FDA UDI | Class II | Unknown |
| Dorma 100 | Dorma 100, BR | FDA UDI | Class II | Unknown |
| BiPAP A30 | BiPAP A30 Ventilator with Humidifier, AU | FDA UDI | Class II | Active |
| Amara Gel | AMARA GEL MASK with RS FRAME and Headgear, Small, JP | FDA UDI | Class II | Unknown |
| DreamWear Full | DreamWear Full Mask Medium Wide, w/Medium Frame w/Headgear, Global | FDA UDI | Class II | Active |
| Circuits | Disposable Pediatric Circuit with H20 Trap | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| A Series | A Series System One Heated Humidifier, INTL | FDA UDI | Class II | Active |
| Bipap | BIPAP DISPOSABLE CIRCUIT | FDA UDI | Class II | Active |
| EverFlo | EVERFLO NON-O2 Percent Indicator 220V, LA, BR | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Pro C-Flex+, w/H Tube Humid, 60 Series, AHP | FDA UDI | Class II | Active |
| Sensor | PLM SENSOR | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Auto CPAP with Bluetooth, ES-PT | FDA UDI | Class II | Unknown |
| DreamWear Full | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro w/Humid w/H Tube, CN | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation CPAP w/Humidifier, w/H Tube, w/WiFi, AHP | FDA UDI | Class II | Unknown |
| ComfortGel | 00 | FDA UDI | Class II | Active |
| REMstar | REMstar, Spain, Oxygen Health | FDA UDI | Class II | Active |
| DreamStation | PWX401H15 | FDA UDI | Class II | Active |
| DreamStation | DreamStation ST 30 with Heated Humidifier, ND | FDA UDI | Class II | Active |
| DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 AE w/Cell, AU | FDA UDI | Class II | Active |
| Dreamwear | 00 | FDA UDI | Class II | Active |
| BiPAP A40 | INX3HCP | FDA UDI | Class II | Active |
| Pico | PICO NASAL MASK W/Headgear, XLarge, JP | FDA UDI | Class II | Unknown |
| DreamWear | 1137430 | FDA UDI | Class II | Active |
| REMstar System (60 Series) | BiPAP Auto BiFlex w/HT Humid System One 60 Series, JP | FDA UDI | Class II | Unknown |
| EverFlo | EVERFLO NON-O2 Percentage Indicator 120V, BR | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Auto CPAP w/Humidifier, w/Cell, US | FDA UDI | Class II | Active |
| Amara | Amara View Mask with Headgear, Small, JP | FDA UDI | Class II | Unknown |
| BiPAP A40 | INX3000S19 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro, ND | FDA UDI | Class II | Unknown |
| SimplyGo Mini | SimplyGo Mini with Standard Battery, IKK | FDA UDI | Class II | Active |
| DreamStation | 01 | 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