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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 49 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OmniLab Advanced Plus | OmniLab Advanced Plus with Humidifier, US | FDA UDI | Class II | Active |
| Amara | AMARA MASK with RS FRAME AND RS Headgear, Small, Japan | FDA UDI | Class II | Unknown |
| Alice 6 | Alice 6 ConversionUpgrade, LDx, INTL | FDA UDI | Class II | Active |
| Pico | 00 | FDA UDI | Class II | Active |
| Sensor | AIR FLOW SENSOR 1 CHANNEL NEONATE | FDA UDI | Class II | Active |
| NightBalance | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP, Latin America | FDA UDI | Class II | Unknown |
| BiPAP A40 | DEX3100S13 | FDA UDI | Class II | Active |
| BiPAP ST | BiPAP S/T C Series Core Pack w/Heated Tube, AHP | FDA UDI | Class II | Active |
| Amara | AMARA MASK with RS FRAME AND Headgear, Medium, Japan | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation BiPAP AVAPS30 AAM w/Humidifier, TR | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro w/Humid w/H Tube. w/Cell, AU | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro, US | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced System One, 60 Series, US | FDA UDI | Class II | Active |
| Sensor | Airflow Sensor Thermistory 1 Pediatric Embletta | FDA UDI | Class II | Active |
| Af541 | 00 | FDA UDI | Class II | Active |
| Amara | AMARA MASK with RS FRAME AND RS Headgear, Petite, US | FDA UDI | Class II | Active |
| ComfortGel | 00 | FDA UDI | Class II | Active |
| Ptaf | PTAFLITE,UNFILTERED AF ONLY | FDA UDI | Class II | Active |
| Trilogy | Trilogy Active Flow Exhalation Circuit, Pediatric | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP with Humidifier, CA | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class I | Active |
| Af541 | AF541Mask EE, LEAK1, UnderNose, 4-PT HDGR, XS, INTL | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| OmniLab Advanced Plus | OmniLab Advanced Plus, US | FDA UDI | Class II | Active |
| Alice 6 | Alice 6 Conversion, LDE, INTL | FDA UDI | Class II | Active |
| Alice NightOne | Alice NightOne, Korea | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP w/Humidifier, w/WiFi, IT | FDA UDI | Class II | Active |
| System One | System One Heated Humidifier, SE | FDA UDI | Class II | Active |
| BiPAP A40 | CAX3100T12 | FDA UDI | Class II | Active |
| Trilogy | R1040005B | FDA UDI | Class II | Active |
| REMstar System One 50 Series | REMstar Auto A-Flex, CN | FDA UDI | Class II | Unknown |
| DreamWear | DreamWear Nasal Mask Kit, Small Medium with Headgear, Global | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP w/Humidifier, IT | FDA UDI | Class II | Unknown |
| DreamWear | 1137388 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP w/WiFi, AHP | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class II | Active |
| PerforMax | PerforMax Mask with EE, Single Patient Use, Xlarge | FDA UDI | Class II | Active |
| BiPAP A30 | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP S/T 25, EU | FDA UDI | Class II | Active |
| BiPAP AVAPS | BiPAP AVAPS C Series, Vitalvent EVO | FDA UDI | Class II | Active |
| Trilogy 100 | Trilogy 100 Ventilator, w/ Bluetooth, Japan | FDA UDI | Class II | Unknown |
| PerformaTrak | PerformaTrak EE Mask w 4 PT Headgr, SU, Medium, CN | FDA UDI | Class II | Unknown |
| DreamWear | DreamWear Under Nose Mask, S, L Frame w/Headgr, Global | FDA UDI | Class II | Active |
| SimplyGo Mini | SimplyGo Mini, KR | FDA UDI | Class II | Unknown |
| DreamWisp | FitPack DreamWisp Mask, Med Connector, w/Headgear, Global | FDA UDI | Class II | Active |
| DreamStation S/T | DreamStation BiPAP S/T30, ES | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP w/Humidifier, w/H Tube, w/Cell, US | FDA UDI | Class II | Active |
| EncoreAnywhere | 2.44 | 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