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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 33 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DreamStation | DreamStation BiPAP AVAPS 30 w/Heated Humidifier, EU | FDA UDI | Class II | Active |
| ComfortGel Blue | ComfortGel Blue Full Mask, Extra Large, Japan | FDA UDI | Class II | Unknown |
| Amara View | Amara View Mask w/SE, with Headgear, Large, JP | FDA UDI | Class II | Active |
| System One | System One Heated Humidifier, PT | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, Small Child Small, Leak 3, ASM | FDA UDI | Class II | Active |
| Af541 | AF541 Mask EE, Leak 2 with 4-Point Headgear, Medium | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Auto BiFlex with Humidifier, System One 60 Series,NO | FDA UDI | Class II | Active |
| Simplygo | SimplyGo, INTL, IT | FDA UDI | Class II | Active |
| PerforMax | Performax Mask with SE and 4 Point Headgear, MPU, INTL Small | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP, BR | FDA UDI | Class II | Unknown |
| ezRIP | ezRIP Adult Kit, 249, 84" | FDA UDI | Class II | Active |
| CT2 Effort Sensor | 00 | FDA UDI | Class II | Active |
| DreamWisp | DreamWisp Mask, Small, Med Connector w/Headgear, AP | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro w/Humid w/H Tube, w/WiFi, US | FDA UDI | Class II | Active |
| System One Humidifer | System One Heated Humidifier, H&L | FDA UDI | Class II | Active |
| PerforMax | Performax Mask, Single Use with EE, Leak 2 - Single, Small | FDA UDI | Class II | Active |
| Phonix System One 60 Series | PHONIX 3i A-Flex System One 60 Series H&L | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Pro C-Flex+, w/Humid, Sys One 60 Series, FR | FDA UDI | Class II | Active |
| Pico | 00 | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class I | Active |
| DreamStation | DreamStation Auto CPAP with Humidifier, AU | FDA UDI | Class II | Active |
| System One 60 Series | REMstar Plus C Flex, System One 60 Series, FI | FDA UDI | Class II | Active |
| BiPAP A40 | AUX3100S19 | FDA UDI | Class II | Active |
| DreamWear Full | 00 | FDA UDI | Class II | Active |
| Sensor | VELCRO STRAP PLM,LG,41CM-16" | FDA UDI | Class II | Active |
| Ac611 | 00 | FDA UDI | Class I | Active |
| Alice NightOne | Alice NightOne Warranty Device, NA | FDA UDI | Class II | Active |
| DreamWear | DreamWear Under Nose Mask, Med Frame w/Headgr, INTL | FDA UDI | Class II | Active |
| DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 w/Humidifier w/Cell, US | FDA UDI | Class II | Active |
| Alice 6 | LDXS | FDA UDI | Class II | Active |
| BiPAP S/T C-Series | BiPAP S/T C Series, 30cm, NO | FDA UDI | Class II | Active |
| PerformaTrak | PerformaTrak with FEP Procedure Pack, Medium, SA | FDA UDI | Class II | Active |
| BiPAP S/T C-Series | BiPAP S/T C Series, 30cm, CN | FDA UDI | Class II | Unknown |
| BiPAP System One 60 Series | BiPAP Auto BiFlex, w/Humid System One 60 Series LA | FDA UDI | Class II | Unknown |
| BiPAP System One 60 Series | BiPAP Pro C-Flex+ HTHum,BT,SystemOne, 60Series, US | FDA UDI | Class II | Active |
| Trilogy 100 | Trilogy 100 Ventilator, Korea (Vitalaire) | FDA UDI | Class II | Unknown |
| Care Orchestrator Belgium | 1.12 | FDA UDI | Class II | Active |
| Dreamwear | 00 | FDA UDI | Class II | Active |
| DreamMapper Web (DM) | 2.11 | FDA UDI | Class II | Active |
| DreamMapper | 2.7 | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced, 30cm, 60 Series, LA | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE (NE) with 4 point Headgear, Large, USA | FDA UDI | Class II | Active |
| BiPAP | AR1111143 | FDA UDI | Class II | Active |
| System One Humidifier | System One Heated Tube Humidifier, CN | FDA UDI | Class II | Unknown |
| DreamWear | 00 | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Humidifier, ND | FDA UDI | Class II | Active |
| Pico | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP, ES | FDA UDI | Class II | Active |
| DreamWear | DreamWear Under Nose Mask, Med Frame w/Headgear, KR | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation, BiPAP AutoSV with Humidifier, EE | 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