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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 31 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DreamStation | DreamStation Auto BiPAP, FR | FDA UDI | Class II | Active |
| Af421 | AF421 Mask with Entrainment Elbow, Leak 1 , Extra Large, USA | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro w/WiFi, AHP | FDA UDI | Class II | Active |
| Garbin | 00 | FDA UDI | Class II | Active |
| Trilogy | Trilogy Oximetry Interface Kit | FDA UDI | Class II | Active |
| Af541 | AF541Mask EE, Leak 2, Under the Nose, w/Capstrap, Size B, JP | FDA UDI | Class II | Unknown |
| Circuits | Disposable Adult Heated Passive Circuit, NO | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro w/WiFi, US | FDA UDI | Class II | Active |
| Alice 6 | Alice 6 Base Station, LDE, China | FDA UDI | Class II | Unknown |
| DreamWear | 00 | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced w/Humid, System One 60 Srs, AU | FDA UDI | Class II | Unknown |
| Alice PDx | Alice PDx ECG Yoke, US | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP w/WiFi, US | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP with Humidifier, ES | FDA UDI | Class II | Unknown |
| PerforMax | PerforMax Mask with SE, Single Patient Use, Large, USA | FDA UDI | Class II | Active |
| Performax | Performax Mask, SU w/SE, Small, China | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation BiPAP Pro with Humidifier, Latin America | FDA UDI | Class II | Active |
| zRIP | zRIP DuraBelt Sum RT Kit, Adult | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Heated Humidifier, EE | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Plus, w/HT Humid System One 60 Series US | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP, AHP | FDA UDI | Class II | Unknown |
| EncoreAnywhere | 2.31 | FDA UDI | Class II | Active |
| BiPAP A30 | BiPAP A30 Ventilator, AU | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro, EU | FDA UDI | Class II | Active |
| DreamWear Full | DreamWear Full Mask Medium, w/Large Frame w/Headgear, Global | FDA UDI | Class II | Active |
| Af541 | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro, FR | FDA UDI | Class II | Active |
| Pro-Flow | PRO-FLOW NASAL CANNULA, M-F 0.20 x 0.35, Single | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class II | Active |
| Amara View | Amara View Mask Without Headgear, Medium, US | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Pro C-Flex+, w/H Tube Humid, Sys One 60 Series, FR | FDA UDI | Class II | Active |
| DreamWear | DreamWear Under Nose Mask, S, S Frame w/o Headgear, Global | FDA UDI | Class II | Active |
| Millennium M10 | Millennium M10 Oxygen Percentage Indicator Concentrator, US | FDA UDI | Class II | Active |
| Af811 | AF811 Mask w/SE, and Headgear, Small, Single Use | FDA UDI | Class II | Active |
| DreamStation BiPAP ST30 | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP, TR | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Circuit Tubing | Reusable Flexible Tubing, Grey | FDA UDI | Class I | Active |
| DreamStation Go | DreamStation Go Humidifier, WE | FDA UDI | Class II | Active |
| Ac611 | AC611 HFNC, Filtered Exhalation Port Connect Demo Kit | FDA UDI | Class I | Active |
| DreamWisp | DreamWisp Mask, P, Med Connector w/Headgear, RU/C Asia | FDA UDI | Class II | Active |
| Care Orchestrator Essence | 2.1 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro w/Humid w/H Tube. w/WiFi, AHP | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation BiPAP Pro, ZA | FDA UDI | Class II | Active |
| Dorma | Dorma 200, LA | FDA UDI | Class II | Active |
| DreamWisp | Petite - XL DreamWisp LAB Pack, Small - Large Connectors | FDA UDI | Class II | Active |
| DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 w/Humid w/H Tube w/Cell, CA | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP autoSV, CA | FDA UDI | Class II | Active |
| zRIP | PTS zRIP Module | FDA UDI | Class II | Active |
| Trilogy Evo, Japan | JP2110X16B | 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