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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 28 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DreamStation | DreamStation Cellular Modem with Oximetry, CA | FDA UDI | Class I | Active |
| Bluetooth Accessory Module | 00 | FDA UDI | Class I | Active |
| Wisp Pediatric | Wisp Pediatric Standard Elbow Accessory | FDA UDI | Class II | Active |
| Af541 | AF541 Mask, EE, Leak 1, with Capstrap, Small | FDA UDI | Class II | Active |
| DreamStation | Dreamstation Expert w/Humid w/H Tube, w/Cell, CA | FDA UDI | Class II | Active |
| Af541 | AF541 Mask EE, Leak 1, with Capstrap, Small, JP | FDA UDI | Class II | Unknown |
| Broadband | Broadband Modem, EU | FDA UDI | Class I | Active |
| Af421 | AF421 Mask with Entrainment Elbow, Leak 1 , Small, USA | FDA UDI | Class II | Active |
| BiPAP A40 | INX3100S19 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro w/ Auto-Trial, EU | FDA UDI | Class II | Active |
| Trilogy 200 | Trilogy 200 Ventilator, Bluetooth, Japan | FDA UDI | Class II | Unknown |
| Nuance | NUANCE GEL Pillow Mask with Headgear, International | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro BiFlex, Sys One 60 Srs, PT | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced w/H Tube Humid, 60 Series, LA | FDA UDI | Class II | Active |
| Trilogy Evo | TR2110X15B | FDA UDI | Class II | Active |
| SimplyGo | SimplyGo, CN | FDA UDI | Class II | Unknown |
| DreamStation Go | DreamStation Go Auto CPAP with Bluetooth, FS Store, DE | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation BiPAP Pro, AR | FDA UDI | Class II | Active |
| BiPAP AVAPS | BiPAP AVAPS C Series, Private Label, 30cm, INTL | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Auto A-Flex, 60 Series, AHP | FDA UDI | Class II | Active |
| Amara | Amara View Mask with Headgear, Large, JP | FDA UDI | Class II | Unknown |
| Trilogy O2 | Trilogy O2 Ventilator, Japan, Rental | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation CPAP Pro w/Humid w/H Tube, INTL | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A-Flex, BTOOTH System One 60 Series, US | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE, LEAK 1, with 4 PT Headgear, Large, Single Use | FDA UDI | Class II | Active |
| Broadband | Broadband Accessory and WiFi Router, US | FDA UDI | Class I | Active |
| Nuance | Nuance Gel Pillows Mask, USA | FDA UDI | Class II | Unknown |
| Performax | PERFORMAX PEDIATRIC SE, MPU, W/4 PT HEADGEAR, XXSMALL | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP with Humidifier, EU | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP w/Cell, US | FDA UDI | Class II | Active |
| Alice 6 | Alice 6, Base Station, LDx, NA | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto, CN | FDA UDI | Class II | Unknown |
| BiPAP A40 | ESX3000S19 | FDA UDI | Class II | Active |
| System One | System One Heated Tube Humidifier, US | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro BiFlex w/H Tube Humid, Sys One 60 Series, LA | FDA UDI | Class II | Unknown |
| Af541 | AF541 Mask EE, Leak 1, Capstrap, Size XL, JP | FDA UDI | Class II | Unknown |
| DreamMapper Web | 2.21 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro, INTL | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Contour Deluxe | Contour Deluxe Mask and Headgear, SPU, Small, China | FDA UDI | Class II | Unknown |
| Amara View | Amara View Mask without Headgear, Large, US | FDA UDI | Class II | Active |
| Dorma 200 | Dorma 200, with Humidifier, AH | FDA UDI | Class II | Active |
| Af541 | AF541 Mask with SE, WITH 4-PT HEADGEAR, LARGE | FDA UDI | Class II | Active |
| Bipap Avaps | 00 | FDA UDI | Class II | Active |
| Wisp Pediatric | 00 | FDA UDI | Class II | Active |
| BIPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced, 60 Series, 30cm, DE | FDA UDI | Class II | Active |
| Af541 | AF541 Mask EE, Leak 2, Under Nose, 4-PT HEADGR, SIZE B | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP with Humidifier, GB | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AVAPS30 AAM, CA | FDA UDI | Class II | Active |
| Bipap A40 | FRX3000H14 | 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