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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 48 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Trilogy | 00 | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE, Leak 1, Circuit, Neb Elbow, CapStrap, Sm, SU | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP with Humidifier, AHP | FDA UDI | Class II | Unknown |
| Af531 | AF531 Mask EE, LEAK 1, with 4 PT Headgr, Medium, Single Use | FDA UDI | Class II | Active |
| BiPAP AVAPS | BiPAP AVAPS C Series Core Pack, 30cm, US | FDA UDI | Class II | Unknown |
| Amara View | Amara View Mask with Headgear, Small, INTL | FDA UDI | Class II | Active |
| Af531 | AF531 Mask w/SE, with 4 point Headgear, Large, SU | FDA UDI | Class II | Unknown |
| EncoreAnywhere | 2.34 | FDA UDI | Class II | Active |
| BiPAP AVAPS | BiPAP AVAPS C Series, 30cm, INTL | FDA UDI | Class II | Active |
| Performatrak | PERFORMATRAK FULL SE W CAPSTRAP, JP, LARGE | FDA UDI | Class II | Unknown |
| BiPAP A40 | ESX3100H19 | FDA UDI | Class II | Active |
| SimplyGo, Argentina | 00 | FDA UDI | Class II | Active |
| PerforMax | Entrainment Elbow Starter Kit, Base + PerforMax MU 4 PT Headgr | FDA UDI | Class II | Active |
| REMstar SE | REMstar SE Auto, US | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro, GB | FDA UDI | Class II | Unknown |
| Af541 | AF541 Mask with SE, with Capstrap, Medium, JP | FDA UDI | Class II | Unknown |
| DreamWear | DreamWear Under Nose Mask, SM, S Frame w/Headgr, JP | FDA UDI | Class II | Unknown |
| Circuits | Pediatric Invasive Passive Disposable Non-Heated Circuit | FDA UDI | Class II | Active |
| PerforMax | PerforMax Mask w/EE, Leak 2, 4 PT Hdgr, MPU, INTL, XL | FDA UDI | Class II | Active |
| System One | System One Heated Tube Humidifier US | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Auto BiFlex, w/HTD Humid, Sys One 60Srs, AU | FDA UDI | Class II | Unknown |
| DreamMapper App iOS (EMEA) | 2.11 | FDA UDI | Class II | Active |
| Trilogy 100 | Trilogy 100 Ventilator, Korea (Philips) | FDA UDI | Class II | Unknown |
| DreamWear Full | DreamWear Full Mask Medium Wide w/Small-Medium Frame, Global | FDA UDI | Class II | Active |
| PerforMax | Performax Mask w/EE, Leak 2, 4 PT Hdgr, MPU, INTL, Large | FDA UDI | Class II | Active |
| ComfortGel | 00 | FDA UDI | Class II | Active |
| System One | 00 | FDA UDI | Class II | Active |
| SimplyFlo | SimplyFlo, US | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro, BR | FDA UDI | Class II | Unknown |
| BiPAP A40 | BiPAP A40 Silver Series Ventilator, JP | FDA UDI | Class II | Unknown |
| Trilogy O2 | Trilogy O2 Ventilator, w/ Bluetooth, Japan | FDA UDI | Class II | Unknown |
| DreamMapper | DreamMapper Web EMEA - 2 | FDA UDI | Class II | Active |
| DreamMapper Web (APAC) | 2.10 | FDA UDI | Class II | Active |
| Alice 6 | Alice 6 Base Station, LDE, JP | FDA UDI | Class II | Unknown |
| Alice 6 | Alice 6 Pressure Sensor, INTL | FDA UDI | Class II | Active |
| Af421 | AF421 Mask with Standard Elbow, Medium, Global | FDA UDI | Class II | Active |
| CoughAssist | 00 | FDA UDI | Class II | Active |
| DreamWisp | DreamWisp Mask, Petite, Med Connector w/o Headgear, Global | FDA UDI | Class II | Active |
| System One 60 Series | BiPAP Pro BiFlex, w/H Tube Hum, with St Tube, 60 Series, CA | FDA UDI | Class II | Active |
| BiPAP A40 | INX3TCP | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro with Humidifier, BL | FDA UDI | Class II | Active |
| Dorma | Dorma 500 Auto with Humidifier, AU | FDA UDI | Class II | Active |
| Alice 6 | Alice 6 Base Station, LDE, INTL | FDA UDI | Class II | Active |
| ComfortGel Blue | ComfortGel Blue Nasal Mask w/Headgear, Petite, Japan | FDA UDI | Class II | Unknown |
| Af541 | AF541 Mask EE, Leak 1, Under the Nose, Capstrap, Size XS, US | FDA UDI | Class II | Active |
| DreamMapper | 2.5 | FDA UDI | Class I | Active |
| DreamStation | DreamStation CPAP, ND | FDA UDI | Class II | Unknown |
| Trilogy | 00 | FDA UDI | Class II | Active |
| Care Orchestrator | 1.23 | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, Small Child Large, SE, ASM | 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