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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 45 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Wisp Pediatric | 00 | FDA UDI | Class II | Active |
| Trilogy Evo | DS2100X11B | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AVAPS30 AAM, TR | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP w/Humid, w/H Tube, LA | FDA UDI | Class II | Active |
| BiPAP A30 | 00 | FDA UDI | Class II | Active |
| Ac611 | 00 | FDA UDI | Class I | Active |
| Sensor | External Flow Sensor, Ped/Infant | FDA UDI | Class II | Active |
| BiPAP A30 | 00 | FDA UDI | Class II | Active |
| Trilogy Evo | Trilogy Evo, USA | FDA UDI | Class II | Active |
| Af421 | AF421 Mask with Entrainment Elbow, Leak 2, Large, Global | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class I | Active |
| Care Orchestrator | 1.11 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP w/Humidifier, w/H Tube, w/WiFi, US | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP, Latin America | FDA UDI | Class II | Active |
| DreamStation 2 | DreamStation 2 CPAP with Humidifier, Cellular, Bluetooth for BL | FDA UDI | Class II | Active |
| DreamWisp | DreamWisp Mask, LAB PACK, with Headgear | FDA UDI | Class II | Active |
| DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 w/WiFi, US | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro with C-Flex, ES | FDA UDI | Class II | Active |
| Af541 | AF541Mask EE, LEAK1, UnderNose, 4PT HDGR,INTL,SIZE C | FDA UDI | Class II | Active |
| EncoreAnywhere | 2.39 | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, Small Child Small, SE, ASM | FDA UDI | Class II | Active |
| Trilogy | 00 | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| EncorePro | 2.19 | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Plus C-Flex w/ Humid, System One 60 Series, CN | FDA UDI | Class II | Unknown |
| Trilogy | Trilogy 200 Ventilator, U.S.A.-Recert | FDA UDI | Class II | Active |
| Performax | 00 | FDA UDI | Class II | Active |
| Care Orchestrator Japan | 1.11 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP autoSV, AU | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP w/Humidifier, w/WiFi, US | FDA UDI | Class II | Active |
| Af531 | A531 Mask EE, LEAK1, Nebulizing Elbow, W/CapStrap, Large, SU | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A-Flex, wHumid, Sys One 60 Srs, SE | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AVAPS 30 AAM no Bluetooth, EU | FDA UDI | Class II | Active |
| CoughAssist | CoughAssist 70 Series Circuit, Toddler, 6ft | FDA UDI | Class II | Active |
| Trilogy Evo Universal | DS2000X11B | FDA UDI | Class II | Active |
| BiPAP AVAPS | BiPAP AVAPS C Series Core Pack, Heated Tube, 30cm, CA | FDA UDI | Class II | Unknown |
| CT2 Effort Sensor | 00 | FDA UDI | Class II | Active |
| Alice 6 | Alice 6 LDE Headbox, NA | FDA UDI | Class II | Active |
| OmniLab Advanced Plus | OmniLab Advanced Plus with Heated Tube Humidifier, US | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP S/T30, w/Heated Humidifier, IT | FDA UDI | Class II | Active |
| DreamStation Go | BRG502S18 | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation BiPAP AVAPS 30 AE, AU | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AutoSV, EE | FDA UDI | Class II | Active |
| Dorma 500 | Dorma 500 Auto, CA | FDA UDI | Class II | Active |
| Ac611 | AC611 High Flow Nasal Cannula, FEP Connect, Medium, INTL | FDA UDI | Class I | Active |
| DreamStation | DreamStation CPAP Pro with Humidifier, IT | FDA UDI | Class II | Unknown |
| Af811 | AF811 Mask, with Headgear, Small, Single Use | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto, US | FDA UDI | Class II | Active |
| Actiware | Actiware, Software CD, US Gov. - 6 | 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