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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 16 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| REMstar | CN257S | FDA UDI | Class II | Active |
| A Series | A Series System One Heated Humidifier, US | FDA UDI | Class II | Active |
| Alice 6 | Alice 6, Base Station, LDx, China | FDA UDI | Class II | Unknown |
| Af541 | AF541 Mask, EE, Leak 1 with Capstrap, Large | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Pro C-Flex+, BlueTooth Sys One 60 Series, US | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro, AHP | FDA UDI | Class II | Unknown |
| Alice PDX Assembly, JP | JAPAN | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP, BR | FDA UDI | Class II | Unknown |
| Amara Gel | AMARA GEL MASK with RS FRAME and Headgear, Medium, US | FDA UDI | Class II | Active |
| Pressure Valve | Pressure Valve | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Plus CFlex, System One 60 Series, SE | FDA UDI | Class II | Active |
| Cannula | Cannula Adaptor Kit | FDA UDI | Class II | Active |
| Dorma 200 | Dorma 200, International | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced 60 Series, IT | FDA UDI | Class II | Active |
| DreamMapper | 2.22 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP w/Humidifier, w/WiFi, CA | FDA UDI | Class II | Active |
| Amara View | 00 | FDA UDI | Class II | Active |
| Alice 6 | Alice 6 LDxS Headbox, China | FDA UDI | Class II | Unknown |
| Nuance Pro | Nuance Pro Gel Pillows Mask with headgear, Japan | FDA UDI | Class II | Unknown |
| EncorePro 2, Software | 2.21 | FDA UDI | Class II | Active |
| DreamWisp | DreamWisp Mask, Medium, Med Connector w/Headgear, APr, AP | FDA UDI | Class II | Active |
| Dorma 500 | Dorma 500 Auto, BR | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation BiPAP AVAPS30 w/Humidifier, IT | FDA UDI | Class II | Active |
| REMstar SE | REMstar SE Auto with Heated Humidifier, w/SD Slot, CA | FDA UDI | Class II | Active |
| BiPAP A40 | BiPAP A40 EFL, AR | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A-Flex, w/H Tube Humid, 60 Series, AHP | FDA UDI | Class II | Active |
| Af541 | AF541 Mask, SE, Under Nose, 4 PT HEADGEAR, SIZE A | FDA UDI | Class II | Active |
| DreamStation | DreamStation Cellular Modem with Oximetry, AU | FDA UDI | Class I | Active |
| DreamMapper | 2.17 | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, Small Child Med, Leak 3, ASM | FDA UDI | Class II | Active |
| EverFlo | EverFlo w/Oxygen Percentage Indicator, 230V, IKK | FDA UDI | Class II | Active |
| DreamWear | DreamWear Under Nose Mask, S, S Frame w/Headgr, Global | FDA UDI | Class II | Active |
| REMstar | CN457HS | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP with Humidifier, BL | FDA UDI | Class II | Active |
| BIPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced, 60 Series, 30 cm, US | FDA UDI | Class II | Active |
| DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 w/Cell, CA | FDA UDI | Class II | Active |
| BiPAP A40 | ITX3000T21 | FDA UDI | Class II | Active |
| Dorma | Dorma 200, US | FDA UDI | Class II | Active |
| Dorma | CNV507 | FDA UDI | Class II | Active |
| DreamStation BiPAP autoSV | Dreamstation BiPAP autoSV, no Bluetooth, LA | FDA UDI | Class II | Active |
| Alice NightOne | Alice NightOne System, Nonin, NA | FDA UDI | Class II | Active |
| DreamWisp | DreamWisp Mask, Large, Med Connector w/Headgear, Global | FDA UDI | Class II | Active |
| PerforMax | Performax Mask w/EE, Leak 2, 4 PT Hdgr, MPU, INTL, Small | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Pro C-Flex, System One 60 Series, France | FDA UDI | Class II | Unknown |
| ezRIP | ezRIP Adult Kit, 249, 16"/24" | FDA UDI | Class II | Active |
| DreamStation | DreamStation Postponement | FDA UDI | Class II | Active |
| Remstar Passover Humidifier | REMstar Passover Humidifier | FDA UDI | Class II | Unknown |
| System One 60 Series | REMstar Pro C-Flex+, Sys One, 60 Srs,ZA | FDA UDI | Class II | Active |
| REMstar System (60 Series) | BiPAP Pro BiFlex w/Humidifier, System One 60 Srs, LA | FDA UDI | Class II | Unknown |
| Fitlife | FitLife Mask with Headgear, Large, 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