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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 12 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BiPAP System One 60 Series | BiPAP Auto BiFlex, System One 60 Series, NO | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| REmstar System One 60 Series | REMstar Pro C-Flex+, System One 60 Series CN | FDA UDI | Class II | Unknown |
| Trilogy | Trilogy 100 Ventilator, China | FDA UDI | Class II | Unknown |
| BiPAP V30 Auto | BiPAP V30 Auto, US | FDA UDI | Class II | Active |
| Performatrak | PerformaTrak Mask with Headgear, Disposable, Small, USA | FDA UDI | Class II | Active |
| Af531 | AF531 EE, Leak 1, Neb Elbow, with CapStrap, SU, Medium, US | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go CPAP with Bluetooth, CA | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro with Humidifier, KR | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMStar Auto w/BlueTooth, US | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro w/Humidi w/H Tube, INTL | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, Small Child Medium, Leak 3, Single Use | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AVAPS30 AAM w/Humidifier, BL | FDA UDI | Class II | Active |
| DreamWear Full | DreamWear Full Mask Small, w/ Large Frame w/o Headgear, Global | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced with Humidifier, 60 Series, CN | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation CPAP, AR | FDA UDI | Class II | Active |
| DreamStation | DreamStation Heated Humidifier, US | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP S/T30 AAM, no Bluetooth, ZA | FDA UDI | Class II | Active |
| REMstar | REMstar, with Humidifier, INTL | FDA UDI | Class II | Unknown |
| Care Orchestrator | 1.7 | FDA UDI | Class II | Active |
| Alice 6 | Alice 6 LDE Headbox, INTL and Brazil | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Auto CPAP with Bluetooth, BL | FDA UDI | Class II | Unknown |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced, 60 Series, JP | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation BiPAP Pro, BL | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Trilogy | R1054260B | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro w/Humid w/H Tube. w/Cell, US | FDA UDI | Class II | Active |
| DreamStation 2 | DreamStation 2 Advanced Auto CPAP with Humidifier, Cellular, Bluetooth for BL | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Plus C-Flex, System One 60 Series, Latin America | FDA UDI | Class II | Active |
| BiPAP A40 | BiPAP A40 Ventilator, AU | FDA UDI | Class II | Unknown |
| DreamWear | 1137381 | FDA UDI | Class II | Active |
| Af541 | AF541 Mask with Standard Elbow, with Capstrap, Small, JP | FDA UDI | Class II | Unknown |
| SimplyGo Mini | SimplyGo Mini, SA | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | System One Heated Humidifier US | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AVAPS 30 AE No Bluetooth. INTL | FDA UDI | Class II | Active |
| BiPAP A40 | GBX3100S19 | FDA UDI | Class II | Active |
| DreamMapper | 2.6 | FDA UDI | Class I | Active |
| Performatrak | PERFORMATRAK FULL FACE MASK W CAPSTRAP,JPN, LARGE | FDA UDI | Class II | Unknown |
| DreamMapper | 2.20 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP with Humidifier, GB | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro, GB | FDA UDI | Class II | Active |
| PLV Circuit Accessories | 00 | FDA UDI | Class II | Active |
| Dorma 200 | Dorma 200, BR | FDA UDI | Class II | Unknown |
| DreamWear | DreamWear Under Nose Mask, Wide, M Frame w/Headgr, JP | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Auto CPAP, AHP | FDA UDI | Class II | Unknown |
| Amara Gel | AMARA GEL MASK SE WITH RS FRAME AND HEADGEAR INTL, PETITE | FDA UDI | Class II | Active |
| PerforMax | 00 | FDA UDI | Class II | Active |
| Af541 | AF541 EE Leak 2 UTN, FOUR POINT HEADGEAR, EXTRA SMALL | FDA UDI | Class II | Active |
| REMstar SE | REMstar SE Auto with Humidifier, with SD Slot, CA | FDA UDI | Class II | Active |
| Alice 6 | Alice 6 LDxN Headbox, China | FDA UDI | Class II | Unknown |
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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