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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 4 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DreamMapper | 2.8 | FDA UDI | Class II | Active |
| Af541 | AF541Mask EE, Leak1, UnderNose, 4PT Hdgr, SizeC, US | FDA UDI | Class II | Active |
| Care Orchestrator | 1.15 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro with Humidifier, TR | FDA UDI | Class II | Active |
| BiPAP AVAPS | BiPAP AVAPS C Series, 30CM, ND | FDA UDI | Class II | Active |
| DreamWear | 1137438 | FDA UDI | Class II | Active |
| Af811 | Standard Elbow Starter Kit, CapStrap plus AF811 | FDA UDI | Class II | Active |
| DreamMapper Web (DM) | 2.15 | FDA UDI | Class II | Active |
| DreamMapper Web (EMEA) | 2.13 | FDA UDI | Class II | Active |
| Trilogy | RJ9 to 2.5mm 3" Female Adapter Cable | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP S/T30 AAM BL | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro w/Humidifier, w/H Tube, US | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Cellular Modem with Oximetry, Flagship, US | FDA UDI | Class I | Active |
| DreamWisp | DreamWisp Mask, Xlarge, Med Connector w/o Headgear, Global | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro with Humidifier, ES | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, JPN, Child Med, SE, ASM | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A-Flex w/HT Humid System One 60 Series JP | FDA UDI | Class II | Unknown |
| DreamWear | DreamWear Under Nose Mask, L Frame w/ Headgear, CN | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation CPAP Pro with Humidifier, ND | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation CPAP, INTL | FDA UDI | Class II | Active |
| E30 | E30 Ventilator | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP S/T 30 with Heated Humidifier, GB | FDA UDI | Class II | Active |
| A Series Humidifier | 00 | FDA UDI | Class II | Active |
| Af541 | AF541 Mask EE, Leak 1, with Capstrap, Large, JP | FDA UDI | Class II | Unknown |
| Af421 | AF421 Mask, with Entrainment Elbow, Leak 1, Large, USA | FDA UDI | Class II | Active |
| BiPAP A40 | BiPAP A40 EFL, BR | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced w/Humidifier, 30cm, 60 Series, US | FDA UDI | Class II | Unknown |
| DreamMapper | 2.24 | FDA UDI | Class II | Active |
| DreamMapper Mobile App Android (APAC) | 2.10 | FDA UDI | Class II | Active |
| EncoreBasic | 2.11 | FDA UDI | Class I | Active |
| Amara | AMARA MASK w/SE, with RS FRAME, RS Headgear, Small, JP | FDA UDI | Class II | Unknown |
| Trilogy | RTO1040005B | FDA UDI | Class I | Active |
| Wisp | Wisp Mask, w/SE, Clear Frame, with Headgear, China | FDA UDI | Class II | Unknown |
| Af531 | AF531 Mask EE, Leak1 with CapStrap, Small, China | FDA UDI | Class II | Unknown |
| BiPAP System One 60 Series | BiPAP Auto BiFlex, w/Humid System One 60 Series,US | FDA UDI | Class II | Active |
| DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 AAM, Linde EOLUS | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP w/Humidifier, w/Heated Tube, US | FDA UDI | Class II | Active |
| Alice 6 | Alice 6, Accessory Sensor Kit, Infant, INTL | FDA UDI | Class II | Active |
| Ac611 | AC611 High Flow Nasal Cannula, 22mm (M), Medium, NA | FDA UDI | Class I | Active |
| Alice PDx | Alice PDx Sleep Diagnostic System, CN | FDA UDI | Class II | Unknown |
| Amara | AMARA MASK with RS FRAME and RS Headgear, Large, Japan | FDA UDI | Class II | Unknown |
| Pico | 00 | FDA UDI | Class II | Active |
| Af541 | AF541 Mask with SE, WITH 4-PT HEADGEAR, SMALL | FDA UDI | Class II | Active |
| DreamStation | DreamStation Heated Humidifier, ES | FDA UDI | Class II | Active |
| Sensor | ALICE 3 COMPAT BODY POSITION | FDA UDI | Class II | Active |
| Care Orchestrator | 1.10 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro w/ Auto-Trial and Humidifier, ES | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP w/Cell, CA | FDA UDI | Class II | Active |
| BiPAP AVAPS | 00 | 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