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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 55 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Amara | AMARA STARTER KIT, Medium | FDA UDI | Class II | Active |
| Amara View | 00 | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro BiFlex, System One 60 Series, ND | FDA UDI | Class II | Active |
| Pro-Tech | AIRFLOW SENSOR THERMISTOR | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Plus C Flex, w/Humid, Sys One 60 Series, SE | FDA UDI | Class II | Active |
| System One | System One Heated Tube Humidifier, INTL | FDA UDI | Class II | Active |
| DreamMapper | 2.8 | FDA UDI | Class II | Active |
| DreamStation | 00606959027916 | FDA UDI | Class II | Active |
| Dorma | Dorma 200, with Humidifier, CN | FDA UDI | Class II | Unknown |
| System One | System One Heated Tube Humidifier, Norway | FDA UDI | Class II | Active |
| Trilogy | Trilogy 202 Ventilator, United States | FDA UDI | Class II | Active |
| EverFlo | EVERFLO w/Oxygen Percentage Indicator, 120V US, CA | FDA UDI | Class II | Active |
| REMStar System One 60 Series | REMStar Pro, w/BlueTooth, US | FDA UDI | Class II | Active |
| zRIP | zRIP Durabelt, Belt Only, Pediatric | FDA UDI | Class II | Active |
| BiPAP A40 | CAX3000T12 | FDA UDI | Class II | Active |
| DreamMapper | DreamMapper Mobile App Android, North America Instance - 2 | FDA UDI | Class II | Active |
| DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS 30, GB | FDA UDI | Class II | Active |
| DreamStation | DreamSt BiPAP AVAPS 30 AE w/HTD Humid, No Btooth, INTL | FDA UDI | Class II | Active |
| BiPAP S/T C-Series | BiPAP Harmony S/T, DE | FDA UDI | Class II | Unknown |
| FitLife | FitLife with Headgear, Extra Large, US | FDA UDI | Class II | Active |
| REMstar System One 50 Series | REMstar Auto A-Flex with Humidifier, with SD Card, China | FDA UDI | Class II | Unknown |
| BiPAP ST | 00 | FDA UDI | Class II | Active |
| DreamMapper | DreamMapper iOS, North American Instance - 2 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Wi-Fi Accessory with Oximetry, PRI, EU | FDA UDI | Class I | Unknown |
| Amara Gel | AMARA GEL MASK with RS FRAME and Headgear, Petite, JP | FDA UDI | Class II | Unknown |
| Af541 | AF541 Mask EE, Leak 1 w/ 4 Point Headgear,Medium | FDA UDI | Class II | Active |
| DreamWear Gel Pillow | DreamWear Gel Pillows Mask, Small Frame w/Hgr, CN | FDA UDI | Class II | Unknown |
| Sensosr | AIR FLOW SENSOR 1 CH.PEDIATRIC CANN.STYLE | FDA UDI | Class II | Active |
| Pro-Tech | STARDUST PTAF | FDA UDI | Class II | Active |
| FitLife | FitLife without Headgear, Extra Large, US | FDA UDI | Class II | Active |
| Snore Sensor | SNORE SENSOR | FDA UDI | Class II | Active |
| zRIP | zRIP Durabelt, Adult, Large | FDA UDI | Class II | Active |
| Amara | 00 | FDA UDI | Class II | Active |
| FitLife | FitLife Lab Mask, Extra Large, US | FDA UDI | Class II | Active |
| Contour Deluxe | Contour Deluxe Mask and Headgear, SPU, Med/Large, INTL | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced System One 60 Series, AU | FDA UDI | Class II | Unknown |
| Wisp | Wisp Nasal Mask with Headgear, Fabric Frame, Petite, Japan | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Plus, 60 Series, CA | FDA UDI | Class II | Active |
| Performatrak | PerformaTrak Mask with Headgear, Disposable, Large, USA | FDA UDI | Class II | Active |
| EverFlo | EverFlo w/Oxygen Percentage Indicator, 230V, AU | FDA UDI | Class II | Active |
| Performatrak | PERFORMATRAK FULL SE W CAPSTRAP, LARGE | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AutoSV, DE | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A-Flex, w/H Tube Humid, 60 Series, AU | FDA UDI | Class II | Active |
| Wisp | Wisp Mask, Clear Frame, without headgear, Large, US | FDA UDI | Class II | Active |
| BiPAP A40 | 00 | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro BiFlex with Humidifier, System One 60 Series, FI | FDA UDI | Class II | Active |
| Performax | Performax Mask w/SE, with 4 PT Headgear, Large, MPU, China | FDA UDI | Class II | Unknown |
| zRIP | zRIP DuraBelt Kit, Adult, Alice 6 | 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