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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 21 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Wisp Pediatric | Wisp Pediatric Fitpack with Headgear, EE, INTL | FDA UDI | Class II | Active |
| Amara Gel | AMARA GEL MASK with RS FRAME w/o Headgear, Large, US | FDA UDI | Class II | Active |
| EncoreAnywhere | 2.43 | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE, Leak 2, w/CapStrap, Medium, SU | FDA UDI | Class II | Active |
| Care Orchestrator | 1.14 | FDA UDI | Class II | Active |
| Af811 | AF811 with FEP and Filter Procedure Pack, Small, SA | FDA UDI | Class II | Unknown |
| Trilogy | Trilogy100 Ventilator, Latin America | FDA UDI | Class II | Active |
| Af541 | AF541 Mask with SE, WITH 4-PT HEADGEAR, MEDIUM | FDA UDI | Class II | Active |
| Af531 | AF531 Mask, SE with CapStrap, Medium, Single Use | FDA UDI | Class II | Unknown |
| Ptaf | PTAF2 Kit | FDA UDI | Class II | Active |
| PerforMax | Performax Mask, Single Use w/SE, Large | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro w/Humid w/H Tube, LA | FDA UDI | Class II | Active |
| DreamMapper Web (DM) | 2.9 | FDA UDI | Class II | Active |
| DreamMapper | 2.6 | FDA UDI | Class I | Active |
| DreamStation | DreamStation CPAP Pro w/CPAP Check, BR | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Heated Humidifier, GB | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AVAPS 30 w/Heated Humidifier, AAM EE | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Auto CPAP with Bluetooth, CA | FDA UDI | Class II | Active |
| DreamWear Full | DreamWear Full Mask Medium Wide, with Medium Frame w/o Headgear, Global | FDA UDI | Class II | Active |
| DreamWear Full | DreamWear Full Mask Small, with Small-Medium Frame, Global | FDA UDI | Class II | Active |
| DreamStation | DreamStation Heated Humidifier, BL | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced, 60 Series, 30cm, AHP | FDA UDI | Class II | Active |
| DreamStation | DreamStation AVAPS 30, ND | FDA UDI | Class II | Active |
| Amara | Amara View Mask with Headgear, Medium, JP | FDA UDI | Class II | Unknown |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced, 30cm, 60 Series, FR | FDA UDI | Class II | Unknown |
| BiPAP A40 | INX3T | FDA UDI | Class II | Active |
| DreamStation BiPAP ST30 | 00 | FDA UDI | Class II | Active |
| Nuance | Nuance Gel Pillows Mask with headgear, Japan | FDA UDI | Class II | Unknown |
| Af811 | AF811 Mask w/SE, and Headgear, Large, Single Use | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro, AHP | FDA UDI | Class II | Unknown |
| BiPAP S/T C-Series | BiPAP S/T C Series, 30cm, FI | FDA UDI | Class II | Active |
| Comfortfull 2 | COMFORTFULL 2 MASK with SE, LARGE, CHINA | FDA UDI | Class II | Unknown |
| Pico | Pico Traditional Nasal Mask with Headgear, Extra Large | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP with Humidifier, AHP | FDA UDI | Class II | Unknown |
| PerforMax | PERFORMAX Mask with EE, Leak 2, MPU, XLarge, USA | FDA UDI | Class II | Active |
| DreamWear | DreamWear Full Mask, MW, with Sm-Medium Frame, KR | FDA UDI | Class II | Unknown |
| Adult Vel.strap Kit 1.5", Size 3 | VELCRO STRAP | FDA UDI | Class II | Active |
| DreamStation Go | DSG400H11 | FDA UDI | Class II | Active |
| BiPAP A40 | INX3000H19 | FDA UDI | Class II | Active |
| Care Orchestrator | 1.14 | FDA UDI | Class II | Active |
| Actiwatch Spectrum Pro | Actiwatch Spectrum PRO Japan | FDA UDI | Class II | Unknown |
| BiPAP System One 60 Series | BiPAP Pro BiFlex with Humidifier, System One 60 Series, ES | FDA UDI | Class II | Active |
| DreamStation BiPAP autoSV | DreamStation BiPAP autoSV w/Humid w/H Tube w/Cell, US | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Af531 | AF531 Mask w/SE, and 4 PT Headgear, Small, Single Use | FDA UDI | Class II | Active |
| DreamWisp | DreamWisp Mask, Small, Med Connector w/Headgear, RU/C AsiaDreamWisp Mask, Small, | FDA UDI | Class II | Active |
| DreamStation | 01 | FDA UDI | Class II | Active |
| BiPAP A40 | BLX3100S19 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP w/Humidifier, w/Cell, US | FDA UDI | Class II | Active |
| EverFlo | EverFlo w/Oxygen Percentage Indicator, 230V, UK, IE | 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