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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 26 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DreamStation | DreamStation BiPAP Pro, Latin America | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Circuits | Disposable Swivel Passive Exhalation Port | FDA UDI | Class II | Active |
| Exhalation Valve | Dual Limb Active Exhalation Valve | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP, JP | FDA UDI | Class II | Unknown |
| BiPAP AVAPS | BiPAP AVAPS C Series, AHP | FDA UDI | Class II | Active |
| EverFlo | EverFlo w/O2 Percentage Indicator, 230V, EU | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE, Leak 1, Circuit, Neb Elbow, CapStrap, Med, SU | FDA UDI | Class II | Active |
| Af421 | AF421 Mask with Entrainment Elbow, Leak 2, Medium, Global | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Wisp | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP w/Humidifier, w/Heated Tube, CA | FDA UDI | Class II | Active |
| O2 Enrichment Attachment | O2 Enrichment Attachment | FDA UDI | Class I | Active |
| Sensor | CT2 PIEZO RESP EFFORT SEN.ADULT | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Auto BiFlex with Humidifier 60 Series, CA | FDA UDI | Class II | Active |
| Af531 | AF531 Mask, SE with CapStrap, Small, Single Use | FDA UDI | Class II | Unknown |
| Trilogy | Trilogy200 Ventilator, United States | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP w/Humidifier, w/Heated Tube, CN | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Auto CPAP w/Humidifier, w/WiFi, US | FDA UDI | Class II | Active |
| ComfortGel Blue | ComfortGel Blue Full Mask, Medium, Japan | FDA UDI | Class II | Unknown |
| Trilogy | 00 | FDA UDI | Class II | Active |
| Performax | Performax Mask w/SE, Single Use, XSmall, China | FDA UDI | Class II | Unknown |
| OmniLab Advanced Plus | OmniLab Advanced Plus, CN | FDA UDI | Class II | Unknown |
| DreamMapper | 2.8 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AVAPS30 w/Humid w/H Tube,US | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro BiFlex w/Hum Sys One 60 Srs, ND | FDA UDI | Class II | Active |
| Pico | 00 | FDA UDI | Class II | Active |
| Sensor | ADULT VELCRO STRAP KIT 1.5" | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro w/Humid w/Heated Tube, US | FDA UDI | Class II | Active |
| CoughAssist | CoughAssist, FaceMask, Adult Large | FDA UDI | Class II | Active |
| DreamMapper Web China Instance | 2.13 | FDA UDI | Class II | Active |
| BiPAP | Circuit Filter Disp Exhal Port with FEP Filter, Single, INTL | FDA UDI | Class II | Active |
| Performax | Performax Mask, Single Use with EE, Leak 2, Small, China | FDA UDI | Class II | Unknown |
| EncoreAnywhere | 2.44 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AVAPS, Postponement | FDA UDI | Class II | Active |
| Performatrak | PERFORMATRAK FULL SE W CAPSTRAP, INT, LARGE | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP, EE | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP w/WiFi, US | FDA UDI | Class II | Active |
| PerforMax | PerforMax Mask with EE, Single Patient Use, Large, USA | FDA UDI | Class II | Active |
| Alice 6 | Alice 6 Upgrade, LDE, US | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Auto BiFlex, System One 60 Series, DE | FDA UDI | Class II | Unknown |
| BiPAP S/T C-Series | BiPAP S/T C Series, 30cm, US | FDA UDI | Class II | Unknown |
| DreamMapper | 2.6 | FDA UDI | Class I | Active |
| Alice 6 | Alice 6 LDxN Headbox, NA | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Auto with Bluetooth, IT | FDA UDI | Class II | Unknown |
| Nuance Pro | Nuance Pro Gel Pillows Mask with headgear, Lab | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP, AU | FDA UDI | Class II | Active |
| Amara | AMARA MASK w/SE w/RS FRAME and Headgr, Large, JN | FDA UDI | Class II | Unknown |
| DreamWisp | DreamWisp Mask, Medium, Med Connector w/o Headgear, Global | 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