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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 2 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ComfortGel Blue Nasal | ComfortGel Blue Nasal Mask w/SE, w/Headgear, Petite, JP | FDA UDI | Class II | Active |
| System One | System One Heated Humidifier, ND | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP w/Cell, AHP | FDA UDI | Class II | Active |
| REMstar SE | REMstar SE with SD Slot, LA | FDA UDI | Class II | Active |
| CoughAssist | Facemask, Adult, Large, with Hose, Filter, Adapter | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar AutoA-Flex with Humidifier, System One 60 Series, FI | FDA UDI | Class II | Active |
| Fitlife | FitLife Mask with Headgear, w/SE, Small, Japan | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced w/H Tube Humid, 60 Series, CN | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Plus, BR | FDA UDI | Class II | Unknown |
| Sensor | GRASS VELCRO STRAP KIT P | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A-Flex, System One, 60 Series, DE | FDA UDI | Class II | Unknown |
| DreamMapper | 2.24 | FDA UDI | Class II | Active |
| BiPAP A40 | BLX3H | FDA UDI | Class II | Active |
| BiPAP A40 | ITX3000H21 | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Plus, BR | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation CPAP Pro, Latin America | FDA UDI | Class II | Active |
| DreamMapper Web (DM) | 2.10 | FDA UDI | Class II | Active |
| OmniLab Advanced Plus | OmniLab Advanced Plus, INTL | FDA UDI | Class II | Unknown |
| BiPAP System One 60 Series | BiPAP Auto BiFlex, System One 60 Series, ND | FDA UDI | Class II | Active |
| DreamWear | DreamWear Under Nose Mask, Wide, S Frame w/Headgear, JP | FDA UDI | Class II | Unknown |
| PerforMax | Performax Mask w/EE Leak 2, Multi Patient Use, Large, USA | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A-Flex, with Bluetooth, 60 Series, AHP | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP with Humidifier, IT | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Expert, FR | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP, CA | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Auto CPAP with Bluetooth, MY | FDA UDI | Class II | Active |
| EncorePro 2, Software | 2.20 | FDA UDI | Class II | Active |
| Performax | Performax Mask with SE, 4 PT Headgear, MPU, Small, China | FDA UDI | Class II | Unknown |
| Alice 5 | BODY POSITION SENSOR, 249 | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Auto BiFlex, w/HT Humid System One 60 Series, US | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Auto, INTL | FDA UDI | Class II | Active |
| Sensor | PLM SENSOR KIT | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro BiFlex, w/HT Humid System One 60 Series INT | FDA UDI | Class II | Unknown |
| ComfortGel BLue | ComfortGel Blue Nasal Mask w/Headgear, Medium, USA | FDA UDI | Class II | Active |
| Dorma | CNV207 | FDA UDI | Class II | Active |
| OmniLab Advanced Plus | OmniLab Advanced Plus, US | FDA UDI | Class II | Unknown |
| BiPAP A40 | NDX3H | FDA UDI | Class II | Active |
| Af541 | AF541 Mask, SE, Under Nose, w/Capstrap, SIZE A | FDA UDI | Class II | Active |
| DreamStation | DreamStation ST 30, ND | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP with Humidifier, Latin America | FDA UDI | Class II | Active |
| Af541 | 00 | FDA UDI | Class II | Active |
| DreamWear Full | DreamWear Full Mask Large with Small-Medium Frame, INTL | FDA UDI | Class II | Active |
| Af541 | AF541 Mask w/EE, Leak 1, UnderNose, 4PT Hdgr, SizeB, US | FDA UDI | Class II | Active |
| DreamStation | DreamStation Expert w/ WiFi, FR | FDA UDI | Class II | Active |
| CoughAssist | CoughAssist, Facemask, Infant | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE (NE) with 4 point Headgear, Small, USA | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AVAPS 30 AAM, ES | FDA UDI | Class II | Active |
| DreamStation | 01 | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Dorma | Dorma 200, BR | FDA UDI | Class II | Unknown |
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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