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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 56 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Performatrak | Performatrak SE Mask w/Headgear, Disp, LARGE, KR | FDA UDI | Class II | Unknown |
| Cbl, High Lev Out, 18 F Ph | CBL | FDA UDI | Class II | Active |
| Optilife | 00 | FDA UDI | Class II | Active |
| Dorma | Dorma 500 Auto with Humidifier, LA | FDA UDI | Class II | Active |
| DreamWear Full | DreamWear Full Mask Large, w/mall Frame w/Headgear, Global | FDA UDI | Class II | Active |
| Trilogy | Trilogy 100 Ventilator, Brazil | FDA UDI | Class II | Unknown |
| DreamMapper | 2.6 | FDA UDI | Class I | Active |
| Battery | PAP Li Ion Battery Kit, Sleep, China | FDA UDI | Class II | Unknown |
| Trilogy EV300, USA | DS2200X11B | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP, AHP | FDA UDI | Class II | Unknown |
| ezRIP | ezRIP, Thorax, 249, 16 inch | FDA UDI | Class II | Active |
| Wisp | 1137366 | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro BiFlex, w/Htd Humid, Sys One 60 Srs, AHP | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro BiFlex, w/HT Humid System One 60 Series, CN | FDA UDI | Class II | Unknown |
| Alice 6 | Alice 6 LDx Base Station, INTL (blue) | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro w/Humid w/H Tube. w/Cell, AHP | FDA UDI | Class II | Unknown |
| BiPAP System One 60 Series | BiPAP Auto Bi-Flex, BTOOTH System One 60 Series, US | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro w/ Auto-Trial and Humidifier, EU | FDA UDI | Class II | Active |
| Pico | Pico Traditional Mask Fitpack w/Headgear, S-M, L, XL | FDA UDI | Class II | Active |
| DreamMapper | 2.20 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro, US | FDA UDI | Class II | Active |
| Alice PDx | Alice PDx Unit Only, Warranty Replacement, US | FDA UDI | Class II | Active |
| Broadband | Broadband Modem, APAC | FDA UDI | Class I | Unknown |
| REMstar System One 60 Series | REMstar Pro C-Flex+w/Hum, SysOne 60 Series, ZA | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP autoSV w/Humid, No Bluetooth, EU | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Auto CPAP with Bluetooth, TR | FDA UDI | Class II | Active |
| Amara | AMARA MASK with RS FRAME w/o Headgear, Small, US | FDA UDI | Class II | Active |
| Nuance Pro | Nuance Pro Gel Pillows Mask, without headgear, Medium, USA | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP w/Humid w/H Tube, w/WiFi, CA | FDA UDI | Class II | Active |
| DreamMapper | 2.6 | FDA UDI | Class I | Active |
| DreamStation | DreamStation Auto BiPAP w/Humidifier, w/Cell, CA | FDA UDI | Class II | Active |
| System One | System One Heated Tube Humidifier, ND | FDA UDI | Class II | Active |
| DreamWisp | DreamWisp Mask, Large, Med Connector w/Headgear, RU/C Asia | FDA UDI | Class II | Active |
| A Series Heated Huminifier | 00 | FDA UDI | Class II | Active |
| EverFlo | EVERFLO QUIET w/O2 Percent Indicator, 120V, UltraFill, US | FDA UDI | Class II | Unknown |
| Trilogy 200 | Trilogy 200 Bluetooth, U.S.A. | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP with Humidifier, Praxair, PT | FDA UDI | Class II | Active |
| ComfortGel | 00 | FDA UDI | Class II | Active |
| Performatrak | PERFORMATRAK FULL SE W CAPSTRAP, MEDIUM | FDA UDI | Class II | Active |
| OmniLab Advanced Plus | OmniLab Advanced Plus, KR | FDA UDI | Class II | Unknown |
| DreamWear | DreamWear Under Nose Mask, Wide, L Frame w/Headgear, JP | FDA UDI | Class II | Unknown |
| DreamWear | 00 | FDA UDI | Class II | Active |
| OmniLab Advanced Plus | OmniLab Advanced Plus with Heated Tube Humidifier, INTL | FDA UDI | Class II | Unknown |
| BiPAP System One 60 Series | BiPAP Pro BiFlex w/Humidifier, Sys One 60 Series, NO | FDA UDI | Class II | Active |
| DreamStation | 01 | FDA UDI | Class II | Active |
| BiPAP A40 | IAX3100H19 | FDA UDI | Class II | Active |
| DreamStation Go | CAGH | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AVAPS30 AAM w/Hum,no Bluetooth, ZA | FDA UDI | Class II | Active |
| Af531 | AF531 EE, Leak 1, Neb Elbow, with CapStrap, SU, Small, US | 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