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Sign in to claim this brandRespironics, Inc.
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 30 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DreamStation | DreamStation Auto CPAP with Humidifier, ES | FDA UDI | Class II | Active |
| Care Orchestrator | 1.9 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AutoSV with Humidifier, FR | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced, 60 Series,CN | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Auto A-Flex, 60 Series, CA | FDA UDI | Class II | Active |
| ComfortGel Blue | ComfortGel Blue Full Mask, Large, Japan | FDA UDI | Class II | Unknown |
| BiPAP AVAPS | BiPAP AVAPS C Series, 30cm, FR | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP with Humidifier, ND | FDA UDI | Class II | Active |
| Care Orchestrator Essence | 4.0.0 | FDA UDI | Class II | Active |
| REMstar System One, 60 Series | REMstar Auto A-Flex, System One 60 Series, FR | FDA UDI | Class II | Unknown |
| BiPAP A40 | 00 | FDA UDI | Class II | Active |
| Wisp | Wisp Nasal Mask w/SE, with Headgear, Clear Frame, JP | FDA UDI | Class II | Unknown |
| A Series Humidifier | A Series System One Heated Humidifier, US | FDA UDI | Class II | Active |
| Amara | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP, DE | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Contour Deluxe | Contour Deluxe Mask and Headgear, SPU, Small, INTL | FDA UDI | Class II | Active |
| Ac611 | AC611 High Flow Nasal Cannula, FEP Connect, Medium, US | FDA UDI | Class I | Active |
| REMstar System One 60 Series | REMstar Plus C-Flex, w/Humid, Sys One 60 Series, GB | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP with Humidifier, BL | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A-Flex System One 60 Series FR | FDA UDI | Class II | Unknown |
| Nebulizing Elbow | EE Nebulizing Elbow Kit, Single, CN | FDA UDI | Class II | Unknown |
| Fitlife | FitLife Mask without Headgear, Small, US | FDA UDI | Class II | Active |
| DreamWear Gel Pillow | DreamWear Gel Pillows Mask, Large Frame w/Hgr, CN | FDA UDI | Class II | Active |
| Sensor | AIR FLOW,THER.10K,ADULT,1 CH,1.5MM SAFETY | FDA UDI | Class II | Active |
| DreamMapper | 2.20 | FDA UDI | Class II | Active |
| DreamStation BiPAP AVAPS | DreamSt BiPAP AVAPS30 w/Humid, AAM,VitalAire,Vitalvent | FDA UDI | Class II | Active |
| EncoreAnywhere | 2.41 | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A-Flex w/HT Humid, BTOOTH Sys One 60 Srs, US | FDA UDI | Class II | Active |
| DreamMapper Web (EMEA) | 2.11 | FDA UDI | Class II | Active |
| CoughAssist | CoughAssist 70 Series Circuit, Adult Small, 6 ft | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Pro C-Flex+ w/HT Humid, BTOOTH Sys One 60 Srs, US | FDA UDI | Class II | Active |
| Pro-Tech | AIRFLOW SENSOR 1 | FDA UDI | Class II | Unknown |
| Af541 | AF541 Mask, EE, Leak 2, Under the Nose, with CAPSTRAP, XS | FDA UDI | Class II | Active |
| DreamStation | 15MM Heated Tube, China | FDA UDI | Class II | Unknown |
| BiPAP AVAPS | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro w/WiFi, FR | FDA UDI | Class II | Active |
| Af811 | AF811 Mask, w/SE, with Headgear, Large, Single Use | FDA UDI | Class II | Active |
| BiPAP A40 | 00 | FDA UDI | Class II | Active |
| EncoreAnywhere | 2.39 | FDA UDI | Class II | Active |
| Trilogy 202 | Trilogy 202 Ventilator, Russia | FDA UDI | Class II | Active |
| BiPAP A30 | 00 | FDA UDI | Class II | Active |
| Performax | PERFORMAX Mask with EE, Leak 2, XXSmall, Single Use | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP, BL | FDA UDI | Class II | Active |
| DreamWear | DreamWear Under Nose Mask, SM , L Frame w/Headgr, JP | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Heated Humidifier, JP | FDA UDI | Class II | Unknown |
| DreamMapper | DreamMapper App iOS, Asia-Pacific Instance - 2 | FDA UDI | Class II | Active |
| Af811 | AF811 Mask w/SE, and Headgear, Medium, Single Use | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP S/T30 AAM w/Hum, no Bluetooth, ZA | FDA UDI | Class II | Active |
| REMstar System (60 Series) | BiPAP Auto BiFlex w/Humid System One 60 Series, JP | 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