Is this your brand? Sign in to claim ownership.
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 23 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DreamStation | DreamStation Auto BiPAP w/Humidifier, w/WiFi, AHP | FDA UDI | Class II | Unknown |
| PRI Cellular Modem, Australia, Canada | PRI Cellular Modem, AU, CA | FDA UDI | Class I | Active |
| A Series Heated Humidifier | 00 | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Auto BiFlex System One 60 Series LA | FDA UDI | Class II | Unknown |
| Amara Gel | AMARA GEL MASK w/SE, with RS FRAME, Headgear, Medium, JP | FDA UDI | Class II | Unknown |
| BiPAP A30 | BiPAP A30 Ventilator, CA | FDA UDI | Class II | Active |
| DreamMapper Mobile App Android (EMEA) | 2.11 | FDA UDI | Class II | Active |
| DreamStation BiPAP autoSV | DreamStation BiPAP autoSV with WiFi, FR | FDA UDI | Class II | Active |
| BiPAP A40 | NDX3100H19 | FDA UDI | Class II | Active |
| DreamWisp | DreamWisp Mask, XL, Med Connector w/Headgear, CEE | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced, 60 Series, 30cm, AU | FDA UDI | Class II | Unknown |
| RUSleeping RTS | RUSLEEPING RTS | FDA UDI | Class II | Active |
| Performax | PERFORMAX Mask with SE, XXSmall, Single Use | FDA UDI | Class II | Active |
| DreamStation BiPAP ST30 | 00 | FDA UDI | Class II | Active |
| BiPAP A40 | DEX3000S13 | FDA UDI | Class II | Active |
| Trilogy | Trilogy EC, U.S.A | FDA UDI | Class II | Active |
| Performatrak | PerformaTrak Full Mask, Medium, with CapStrap, Single Use | FDA UDI | Class II | Active |
| Performatrak | PerformaTrak Mask, Medium, Reusable Pack, INTL | FDA UDI | Class II | Active |
| Af541 | AF541 Mask, EE, LEAK 2 WITH CAPSTRAP, MEDIUM | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP with Humidifier, CNDreamStation Auto CPAP with Humidifier | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation CPAP with Humidifier, GB | FDA UDI | Class II | Unknown |
| Amara Gel | AMARA GEL MASK SE WITH RS FRAME AND HEADGEAR INTL, LARGE | FDA UDI | Class II | Active |
| System One 60 Series | 00 | FDA UDI | Class II | Active |
| Trilogy Evo | Trilogy Evo, O2, Postponement | FDA UDI | Class II | Active |
| zRIP | zRIP Wireset, Medcare | FDA UDI | Class II | Active |
| Piezo Sensor | 00 | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| BiPAP A30 | 00 | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Auto BiFlex, BlueTooth, System One 60 Series, AHP | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP, International | FDA UDI | Class II | Unknown |
| Amara | AMARA MASK with RS FRAME and RS Headgear, Petite, Japan | FDA UDI | Class II | Unknown |
| DreamMapper | 2.20 | FDA UDI | Class II | Active |
| Pico | 00 | FDA UDI | Class II | Active |
| SimplyGo Mini | SimplyGo Mini, IKK | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Pro C-Flex+, 60 Series, AHP | FDA UDI | Class II | Active |
| Trilogy O2 | Trilogy O2 Ventilator,Japan-RECERT | FDA UDI | Class II | Unknown |
| DreamMapper | 2.8 | FDA UDI | Class II | Active |
| Trilogy | Trilogy Passive Exhalation Circuit, Adult | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP autoSV, no Bluetooth, ZA | FDA UDI | Class II | Active |
| Nuance | Nuance Pro Gel Pillows Mask with Headgear, USA | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro with Humidifier, EE | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, JPN, Child Large, SE, ASM | FDA UDI | Class II | Active |
| BiPAP | Circuit Filter Disp Exhal Port w/FEP Filter, Single, INTL | FDA UDI | Class II | Active |
| Performatrak | Performatrak Mask w/SE and Headgr, Med, Disp, INTL | FDA UDI | Class II | Active |
| CoughAssist | 00 | FDA UDI | Class II | Active |
| Nuance | Nuance Gel Pillows Mask, without headgear, Small, USA | FDA UDI | Class II | Unknown |
| DreamMapper Android China Instance | 2.13 | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto JP | FDA UDI | Class II | Unknown |
| DreamMapper Web (APAC) | 2.13 | FDA UDI | Class II | Active |
| DreamWear Full | 1133372UA | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Respironics, Inc. Coyol Alajuela · CR FEI 3027553886