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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 8 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DreamStation | DreamStation CPAP Pro, EE | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP w/Humidifier, w/WiFi, AHP | FDA UDI | Class II | Unknown |
| Wisp | Wisp Mask, Exra Large, Clear Frame, w/Headgear, INTL | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE, Leak 2, with 4 PT Headgear, Large, SU | FDA UDI | Class II | Active |
| DreamMapper | 2.20 | FDA UDI | Class II | Active |
| DreamWisp | DreamWisp Mask, L, Sm/Med Connector, W/Headgear, KR | FDA UDI | Class II | Unknown |
| EncoreAnywhere | EncoreAnywhere - North America Instance - 2 | FDA UDI | Class II | Active |
| Fitlife | FitLife Mask with Headgear, w/SE, Large, Japan | FDA UDI | Class II | Unknown |
| SimplyGo Mini | SimplyGo Mini with Extended Battery, US | FDA UDI | Class II | Active |
| BiPAP A40 | GBX3T | FDA UDI | Class II | Active |
| BiPAP A40 | ESX3T | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE, Leak 2, with 4 PT Headgear, Medium, SU | FDA UDI | Class II | Active |
| kncoreAnywhere - EU Instance | 2.38 | FDA UDI | Class II | Active |
| Af541 | AF541 Mask EE, LEAK 1, Under Nose, CAPSTRAP, INTL, SIZE A | FDA UDI | Class II | Active |
| SimplyGo Mini | SimplyGo Mini with Standard Battery, KR | FDA UDI | Class II | Unknown |
| Actiwatch 2 | Actiwatch 2 Device | FDA UDI | Class II | Active |
| BiPAP SOH | 00 | FDA UDI | Class II | Active |
| Contour Deluxe | 00 | FDA UDI | Class II | Active |
| Af811 | AF811 Mask, with Headgear, Large, Single Use | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Auto BiFlex, BlueTooth, 60 Series, CA | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP, BL | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP, ZA | FDA UDI | Class II | Active |
| EncoreAnywhere | 2.41 | FDA UDI | Class II | Active |
| System One | System One Heated Humidifier, INTL | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A Flex, Sys One, 60 Srs, ND | FDA UDI | Class II | Active |
| PerforMax | Performax Mask with EE and SE, MPU, Leak 2, Small, USA | FDA UDI | Class II | Active |
| EncoreAnywhere | 2.38 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro with Humidifier, BL | FDA UDI | Class II | Active |
| DreamMapper App iOS (EMEA) | 2.13 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP w/Humidifier, w/Heated Tube, KR | FDA UDI | Class II | Unknown |
| A Series | A Series, System One, Heated Humidifier, US | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, INTL, Child Med, Leak 3, Single Use | FDA UDI | Class II | Active |
| Sensor | ONE CHANNEL KIT ADULT 1.5" | FDA UDI | Class II | Active |
| BiPAP A40 | 00 | FDA UDI | Class II | Active |
| Af541 | AF541, Bronchoscopy Elbow, Click Style, JP | FDA UDI | Class II | Unknown |
| Therapy Mask 3100 | Large, Therapy Mask 3100 Silicone Pillow | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro, DE | FDA UDI | Class II | Active |
| Performax | PERFORMAX PEDIATRIC EE LEAK 2, MPU, W/4 PT HEADGR, XXSMALL | FDA UDI | Class II | Active |
| Amara | 00 | FDA UDI | Class II | Active |
| Af541 | AF541 Mask EE, Leak 1, Under the Nose, Capstrap, Size XS, JP | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Auto CPAP w/Humid w/H Tube w/WiFi, US | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Performatrak | PERFORMATRAK FULL w CAPSTRAP,SMALL | FDA UDI | Class II | Active |
| Af541 | AF541 Mask, EE, Leak2, UnderNose, w/CAPSTRAP, SIZE C | FDA UDI | Class II | Active |
| Flow Gen Harmony 2 Domc | 00 | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Pro C-Flex, System One 60 Series, FR | FDA UDI | Class II | Unknown |
| Broadband Modem | Broadband/Oximetry Accessory, JP | FDA UDI | Class I | Unknown |
| SM, DreamWear UtN, Med Frm w HGR, JPN | 00 | FDA UDI | Class II | Active |
| REMstar SE | REMstar SE Auto w/Htd Humid and St Tube, w/SD Slot, CA | FDA UDI | Class II | Active |
| Alice 6 | Alice 6 LDE Headbox, Brazil | 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