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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 50 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BiPAP A40 | FRX3100H14 | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| DreamWear Full | 00 | FDA UDI | Class II | Active |
| Pico | 00 | FDA UDI | Class II | Active |
| CoughAssist | CoughAssist 70 Series, Water Trap | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A-Flex, w/HT Humid System One 60 Srs CN | FDA UDI | Class II | Unknown |
| Circuits | Adult Invasive Passive Disposable Non-Heated Wire Circuit | FDA UDI | Class II | Active |
| Amara Gel | AMARA GEL MASK w/SE, with RS FRAME, Headgear, Large, JP | FDA UDI | Class II | Unknown |
| Af541 | AF541 Mask EE, Leak 1, with 4 Point Headgear, X-Large | FDA UDI | Class II | Active |
| ezRIP, thorax, 1.5, 84", Alice 5 | ezRIP, Thorax, 1.5, 84 inch, Alice | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A Flex w/Hum, Sys One 60 Srs, ND | FDA UDI | Class II | Active |
| EncoreAnywhere | 2.36 | FDA UDI | Class II | Active |
| DreamMapper | 2.8 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP with Humidifier, AR | FDA UDI | Class II | Active |
| Sensor | THERMISTOR SENSOR, ADULT, STARDUST | FDA UDI | Class II | Active |
| Care Orchestrator | 1.20 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Heated Humidifier, ZA | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Pico | Pico Traditional Nasal Mask without Headgear, Extra Large | FDA UDI | Class II | Active |
| Af421 | AF421 Mask with Standard Elbow, Extra Large, Global | FDA UDI | Class II | Active |
| Wisp | Wisp Mask, Small-Medium, Clear Frame, w/Headgear, INTL | FDA UDI | Class II | Active |
| BiPAP A40 | DEX3T | FDA UDI | Class II | Active |
| Ac611 | AC611 High Flow Nasal Cannula, 22 mm (M), Small, INTL | FDA UDI | Class I | Active |
| DreamStation | DreamStation CPAP Pro w/Cell, US | FDA UDI | Class II | Active |
| Ap111 | AP111 Mask w/Headgear, Circuit, Filter, SU, Cradles | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP with Humidifier, US | FDA UDI | Class II | Active |
| DreamMapper | 2.17 | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Auto CPAP with Bluetooth, AU | FDA UDI | Class II | Active |
| Trilogy 200 | Trilogy 200 Ventilator, Bluetooth, Australia | FDA UDI | Class II | Active |
| BiPAP A40 | ITX3T | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| SimplyGo Mini | SimplyGo Mini with Extended Battery, IKK | FDA UDI | Class II | Active |
| Amara | Amara Mask with SE, Medium, with RS Frame and Headgear, INTL | FDA UDI | Class II | Active |
| DreamStation | DreamStation, BiPAP AutoSV with Humidifier, DE | FDA UDI | Class II | Active |
| Pico | Pico Nasal Mask FitPack with Headgear USA | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro with Humidifier, CN | FDA UDI | Class II | Unknown |
| EncoreAnywhere | 2.35 | FDA UDI | Class II | Active |
| CoughAssist | CoughAssist T70, Oximetry Interface Kit | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP S/T25 w/Hum w/H Tube, no BT, INTL | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP with Humidifier, CN | FDA UDI | Class II | Unknown |
| System One | System One Performance Tubing, 6 ft, 15mm | FDA UDI | Class I | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class I | Active |
| DreamStation | DreamStation Auto BiPAP w/WiFi, AHP | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro BiFlex H Tube Humid, St Tube, BTooth, 60 Srs, CA | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE,Leak 1,Circuit, Neb Elbow,Capstrap,SU,Large,US | FDA UDI | Class II | Unknown |
| DreamStation Go | DreamStation Go Auto CPAP with Bluetooth, UK | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class II | Active |
| REMstar SE | REMstar SE Auto with SD Slot, CA | FDA UDI | Class II | Active |
| BiPAP A40 | BiPAP A40 Ventilator w/H Tube Humid, CA | 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