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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 47 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| REMstar System One 60 Series | REMstar Pro C-Flex+, BR | FDA UDI | Class II | Unknown |
| Alice 6 | Alice 6, Accessory Sensor Kit, Adult, INTL | FDA UDI | Class II | Active |
| Snore Sensor | SNORE MICROPHONE | FDA UDI | Class II | Active |
| Optilife | 00 | FDA UDI | Class II | Active |
| Pro-Tech | AIRFLOW SENSOR 1 | FDA UDI | Class II | Active |
| BiPAP A40 | NDX3100S19 | FDA UDI | Class II | Active |
| Alice 6 | LDXN | FDA UDI | Class II | Active |
| Amara | Amara View Mask with Headgear, XS , JP | FDA UDI | Class II | Unknown |
| BiPAP AVAPS | BiPAP AVAPS C Series, 30cm, FI | FDA UDI | Class II | Active |
| DreamWear Full | DreamWear Full Mask Medium, with Small-Medium Frame, Global | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| DreamStation Expert | 00 | FDA UDI | Class II | Active |
| DreamMapper | 2.7 | FDA UDI | Class II | Active |
| DreamStation | DreamStation AVAPS 30 AAM, no Bluetooth, INTL | FDA UDI | Class II | Active |
| DreamMapper Web (DM) | 2.13 | FDA UDI | Class II | Active |
| CoughAssist | E70 | FDA UDI | Class II | Active |
| DreamMapper | 2.20 | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Auto CPAP, P-Flex with Bluetooth, FR | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation BiPAP Pro w/Humid w/H Tube, w/WiFi, CA | FDA UDI | Class II | Active |
| Wisp | Wisp Mask, Fabric Frame, with Headgear, China | FDA UDI | Class II | Unknown |
| DreamWear | 1137380 | FDA UDI | Class II | Active |
| DreamWisp | DreamWisp Mask, XL, Med Connector w/Headgear, AP | FDA UDI | Class II | Active |
| EncoreAnywhere | 2.36 | FDA UDI | Class II | Active |
| BiPAP A30 | BiPAP A30 Ventilator, CN | FDA UDI | Class II | Unknown |
| DreamWisp | DreamWisp Mask, Large, Med Connector, w/Headgear, INTL | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP w/Humid, w/H Tube, AHP | FDA UDI | Class II | Unknown |
| DreamStation | Dreamstation Expert with Humidifier, CA | FDA UDI | Class II | Active |
| Alice PDx | Alice PDx ExG Yoke, US | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Plus CFlex, w/Hum Sys One 60 Srs, ND | FDA UDI | Class II | Active |
| Trilogy | 00 | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Plus, w/H Tube Humid, Standard Tube, 60 Series, CA | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE with CapStrap, Medium, USA | FDA UDI | Class II | Unknown |
| Silver Series | Silver Series Heated Tube Humidifier, DE | FDA UDI | Class II | Active |
| Performatrak | Performatrak Mask with Headgear, Small, Disposable, INTL | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP w/Cell, CA | FDA UDI | Class II | Active |
| Performatrak | PERFORMATRAK SE REUSABLE PACK, LARGE, KOREA | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation CPAP w/Cell, US | FDA UDI | Class II | Active |
| Af541 | AF541 Mask EE, Leak 2 with 4-Point Headgear, Large | FDA UDI | Class II | Active |
| System One 60 Series | REMstar Pro C-Flex+, System One 60 Series, ES | FDA UDI | Class II | Active |
| Invasive Circuit | 00 | FDA UDI | Class II | Active |
| REMstar System (60 Series) | BiPAP Auto BiFlex, System One 60 Series, JP | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Auto CPAP, US | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, INTL, Child Large, SE, Single Use | FDA UDI | Class II | Active |
| Af541 | AF541 Mask EE, Leak 1, Under the Nose, Capstrap, Size A, US | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Pro C-Flex+, w/Humid, System One 60 Srs, PT | FDA UDI | Class II | Active |
| EncoreAnywhere | 2.32 | FDA UDI | Class II | Active |
| RUSleeping RTS | RUSLEEPING RTS | FDA UDI | Class II | Active |
| DreamWear Full | DreamWear Full Mask Medium Wide, w/Small Frame w/Headgear, Global | FDA UDI | Class II | Active |
| PerformaTrak | Performatrak plus Performax Basic Kit, Domestic | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, Small Child Large, SE, Single Use | 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