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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 60 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SimplyGo Mini | SimplyGo Mini, Extended Battery, Argentina | FDA UDI | Class II | Active |
| SimplyGo | SimplyGo, BR | FDA UDI | Class II | Unknown |
| Dorma 400 | Dorma 400, DE | FDA UDI | Class II | Unknown |
| Af531 | AF531 Mask EE, LEAK 2, with 4 PT Headgear, SU, Small, CN | FDA UDI | Class II | Unknown |
| DreamMapper | DreamMapper Android, China Instance - 2 | FDA UDI | Class II | Unknown |
| Sleepware | 3.8 | FDA UDI | Class II | Active |
| Easylife | EasyLife Mask w/Headgear, Large, Japan | FDA UDI | Class II | Unknown |
| DreamStation Go | DreamStation Go CPAP with Heated Humidifier, AU | FDA UDI | Class II | Active |
| Af541 | AF541 Mask, SE, Under Nose, 4 PT HEADGEAR, XSMALL | FDA UDI | Class II | Active |
| External Pulse Oximeter (Nonin XPOD) | External Pulse Oximeter (Nonin XPOD) | FDA UDI | Class II | Active |
| DreamWear Full | DreamWear Full Mask Medium with Small-Medium Frame, INTL | FDA UDI | Class II | Active |
| Wisp | Wisp Mask, Youth Fabric, with Headgear, International | FDA UDI | Class II | Active |
| Af531 | AF531 Mask w/SE, with 4 point Headgear, Small, Single Use | FDA UDI | Class II | Unknown |
| Somnia System One 60 Series | SOMNIA 3i, H&L | FDA UDI | Class II | Active |
| DreamWisp | DreamWisp Mask, Medium, Med Connector, W/Headgear, INTL | FDA UDI | Class II | Active |
| DreamWisp | DreamWisp Mask, Medium, Med Connector w/Headgear, Global | FDA UDI | Class II | Active |
| Amara Gel | AMARA GEL MASK with RS FRAME w/o Headgear, Petite, US | FDA UDI | Class II | Active |
| ezRIP | ezRIP, Abdomen, 1.5, 84 inch, Alice | FDA UDI | Class II | Active |
| Af541 | AF541 Mask EE, Leak 1, Under the Nose, 4 Pt Headgear, XS, US | FDA UDI | Class II | Active |
| Af421 | AF421 Mask with Entrainment Elbow, Leak 1 , Medium, USA | FDA UDI | Class II | Active |
| SimplyGo | SimplyGo, INTL | FDA UDI | Class II | Active |
| Performatrak | PERFORMATRAK FULL SE W CAPSTRAP, JPN, SMALL | FDA UDI | Class II | Unknown |
| DreamWear Full | DreamWear Full Mask Large, w/ Medium Frame w/o Headgear, Global | FDA UDI | Class II | Active |
| DreamStation Go | CAGHCP | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go CPAP with Bluetooth, EU | FDA UDI | Class II | Active |
| Alice 6 | LDE | FDA UDI | Class II | Active |
| Pico | Pico Nasal Mask with Headgear, Large, China | FDA UDI | Class II | Unknown |
| DreamWisp | DreamWisp Mask, XL, Med Connector w/Headgear, RU/C Asia | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Auto CPAP with Bluetooth, FS Store, BL | FDA UDI | Class II | Unknown |
| DreamMapper | 2.23 | FDA UDI | Class II | Active |
| Alice 6 | Alice 6 Base Station, LDE with Masimo, NA | FDA UDI | Class II | Active |
| DreamMapper | 2.17 | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Heated Humidifier, INTL | FDA UDI | Class II | Active |
| Af531 | AF531 Mask w/SE, and CapStrap, Large, Single Use | FDA UDI | Class II | Active |
| Optilife | 00 | FDA UDI | Class II | Active |
| DreamMapper | 2.5 | FDA UDI | Class I | Active |
| Nuance Pro | Nuance Gel Pillows Mask, without headgear, USA | FDA UDI | Class II | Active |
| DreamMapper | 2.23 | FDA UDI | Class II | Active |
| Broadband | Broadband Ethernet Adapter | FDA UDI | Class I | Active |
| Ac611 | AC611 High Flow Nasal Cannula, FEP Connect, Large, NA | FDA UDI | Class I | Active |
| Pn841 | PN841 Mask, Small Child Medium, SE, Single Use | FDA UDI | Class II | Active |
| EverFlo | EVERFLO w/O2 Percentage Indicator, 220V, LA, BR | FDA UDI | Class II | Unknown |
| Af811 | AF811 with FEP and Filter Procedure Pack, Large, SA | FDA UDI | Class II | Unknown |
| EverFlo | EverFlo w/Oxygen Percentage Indicator, 230V, KR | FDA UDI | Class II | Unknown |
| Care Orchestrator | 1.15 | FDA UDI | Class II | Active |
| Nuance Pro | NUANCE PRO GEL PILLOW MASK, W/HEADGEAR, CN | FDA UDI | Class II | Active |
| Sleepware | Sleepware G3 Software, Web download - 3 | FDA UDI | Class II | Active |
| OmniLab Advanced Plus | OmniLab Advanced Plus, JP | FDA UDI | Class II | Unknown |
| Wisp | 00 | FDA UDI | Class II | Active |
| DreamMapper | 2.24 | 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