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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 25 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| System One Humidifier | System One Heated Tube Humidifier, H&L | FDA UDI | Class II | Active |
| ComfortGel Blue | ComfortGel Blue Full Mask, Large, International | FDA UDI | Class II | Active |
| Amara View | Amara View Mask w/SE, with Headgear, Medium, JP | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro w/Humidifier, w/Cell, US | FDA UDI | Class II | Active |
| DreamWear | 1137407 | FDA UDI | Class II | Active |
| Software, EncorePro2, web | 2.22 | FDA UDI | Class II | Active |
| DreamMapper | 2.23 | FDA UDI | Class II | Active |
| Sensor | CT2 A Embletta | FDA UDI | Class II | Active |
| ComfortGel Blue | ComfortGel Blue Nasal Mask w/Headgear, Large, Japan | FDA UDI | Class II | Unknown |
| Care Orchestrator Netherlands | 1.13 | FDA UDI | Class II | Active |
| Af541 | AF541 Mask EE Leak 1, with 4 Point Headgear, Large | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class II | Active |
| Trilogy Evo | Trilogy Evo, Postponement | FDA UDI | Class II | Active |
| Performax | PERFORMAX PEDIATRIC EE LEAK 2, MPU, W/4 PT HEADGR, XSMALL | FDA UDI | Class II | Active |
| PerforMax | PerforMax Mask, Single Patient Use, EE, INTL, Large | FDA UDI | Class II | Active |
| Care Orchestrator | 1.26 | FDA UDI | Class II | Active |
| DreamStation | 01 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP S/T30 AAM w/Humidifier, BL | FDA UDI | Class II | Active |
| BiPAP V30 Auto | 1140184 | FDA UDI | Class II | Active |
| DreamMapper | 2.17 | FDA UDI | Class II | Active |
| DreamStation 2 | DreamStation2 Auto CPAP Advanced with Hu | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP with Humidifier, INTL | FDA UDI | Class II | Unknown |
| System One 60 Series | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro w/Humidifier, w/WiFi, AHP | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Heated Humidifier, Core Pack, US | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP S/T 25, no Bluetooth, EU | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP autoSV w/Humidr w/H Tube, US | FDA UDI | Class II | Active |
| DreamStation Go Humidifier, LATAM | 00 | FDA UDI | Class II | Active |
| System One | System One, Heated Humidifier, ZA | FDA UDI | Class II | Active |
| DreamWisp | DreamWisp Mask, Petite, Sm/Med CONNECTOR, w/Headgear, KR | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Auto A-Flex, System One 60 Series, NO | FDA UDI | Class II | Active |
| BiPAP AVAPS C Series | 00 | FDA UDI | Class II | Active |
| DreamStation BiPAP autoSV | DreamStation BiPAP autoSV w/Humid w/H Tube, w/WiFi, CA | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class I | Active |
| BiPAP A40 | ESX3H | FDA UDI | Class II | Active |
| Care Orchestrator | 1.22 | FDA UDI | Class II | Active |
| DreamStation | 01 | FDA UDI | Class II | Active |
| Dorma | Dorma 500 Auto, with Humidifier, CN | FDA UDI | Class II | Unknown |
| BiPAP System One 60 Series | BiPAP Auto, CA | FDA UDI | Class II | Active |
| Performatrak | Performatrak Mask with Headgear, Disposable, SMALL, Korea | FDA UDI | Class II | Unknown |
| Af531 | AF531 Mask w/SE, w/Reduced Size 4 PT Headgear, SU, Medium | FDA UDI | Class II | Active |
| DreamWear Dm Plw, Demo Pack | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro with Humidifier, Latin America | FDA UDI | Class II | Active |
| System One | System One Heated Humidifier, ES, Oxigen Salud | FDA UDI | Class II | Active |
| FitLife | FitLife Mask with Headgear, Extra Large, Japan | FDA UDI | Class II | Unknown |
| AlicePDx | Alice PDx MobileLink Cable | FDA UDI | Class II | Active |
| DreamStation | DreamStation ST 30 AAM, ND | FDA UDI | Class II | Active |
| Bluetooth | Bluetooth Accessory Module, CA | FDA UDI | Class I | Unknown |
| Amara Gel | AMARA GEL MASK WITH RS FRAME AND HEADGEAR INTL, MEDIUM | FDA UDI | Class II | Active |
| BiPAP A40 | GBX3000T19 | 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