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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 32 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DreamMapper | 2.7 | FDA UDI | Class II | Active |
| BiPAP A40 | BLX3000S19 | FDA UDI | Class II | Active |
| S, AC611 HFNC, 22mm (M), JPN | 00 | FDA UDI | Class I | Active |
| DreamStation | DreamStation BiPAP S/T 30 AAM , No Bluetooth, EU | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP, EE | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, INTL, Child Small, SE, ASM | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Wisp | 00 | FDA UDI | Class II | Active |
| Sleepware | 3.8 | FDA UDI | Class II | Active |
| Af531 | AF531 Mask w/SE, Nebulizing Elbow, w/CapStrap, Small, SU | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Auto CPAP w/Humid w/H Tube, w/WiFi, AHP | FDA UDI | Class II | Unknown |
| Alice 6 | Alice 6 LDE Base Station, INTL | FDA UDI | Class II | Active |
| Trilogy | TRILOGY 202 VENTILATOR, U.S.A-RECERT | FDA UDI | Class II | Active |
| Alice 6 | Alice 6 LDxS Headbox, INTL | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Auto CPAP w/Bluetooth, FS Store, ES-PT | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Auto P-Flex, System One 60 Series, France | FDA UDI | Class II | Unknown |
| Amara | AMARA MASK w/SE, with RS FRAME, Headgear, Medium, CN | FDA UDI | Class II | Unknown |
| BiPAP A40 | ITX3100S21 | FDA UDI | Class II | Active |
| System One | System One Heated Humidifier, ES | FDA UDI | Class II | Active |
| Alice 6 | ALICE 6 | FDA UDI | Class II | Active |
| BiPAP A40 | GBX3100T19 | FDA UDI | Class II | Active |
| Amara View | 00 | FDA UDI | Class II | Active |
| System One | System One Heated Tube Humidifier, JP | FDA UDI | Class II | Unknown |
| Trilogy 200 | Trilogy 200 Ventilator, Bluetooth, Canada | FDA UDI | Class II | Active |
| DreamWear | DreamWear SC Under Nose Mask Fitpack Japan | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation CPAP w/Humidifier, w/Cell, US | FDA UDI | Class II | Active |
| RUSleeping RTS | RUSleeping RTS, China | FDA UDI | Class II | Unknown |
| Wisp | Wisp Mask, Fabric Frame, with Headgear, XL, Japan | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation BiPAP Pro with Humidifier, AHP | FDA UDI | Class II | Unknown |
| Amara View | Amara View Mask without Headgear, Small, US | FDA UDI | Class II | Active |
| Actical | ACTICAL | FDA UDI | Class II | Active |
| Wire Set | REUSABLE WIRE SET | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Pro, JP | FDA UDI | Class II | Unknown |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Af541 | AF541 Mask EE, Leak 1, Under the Nose, 4 Pt HDGR, Size A, US | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Plus, w/H Tube Humid, 60 Series, AHP | FDA UDI | Class II | Unknown |
| Pn841 | PN841 Mask, Small Child Med, SE, ASM | FDA UDI | Class II | Active |
| Pro-Flow | Pro-Flow Nasal Cannula, Pediatric | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE, Leak 1, Circuit with 4 PT Headgr, Large, SU | FDA UDI | Class II | Active |
| ezRIP | EZRIP | FDA UDI | Class II | Active |
| Dorma | Dorma 200, with Humidifier, US | FDA UDI | Class II | Active |
| System One | System One Heated Humidifier, US | FDA UDI | Class II | Active |
| Fitlife | FitLife with Lab Headgear Lab Mask, Large, US | FDA UDI | Class II | Active |
| REMstar | CN257HS | FDA UDI | Class II | Active |
| Pro-Flow | PRO-FLOW MULTIPURPOSE NASAL CANNULA, PEDIATRIC SMALL | FDA UDI | Class II | Active |
| PerforMax | PerforMax Mask with SE, Single Patient Use, Small, USA | FDA UDI | Class II | Active |
| Performatrak | PERFORMATRAK REUSABLE PACK, SMALL, KOREA | FDA UDI | Class II | Unknown |
| OmniLab Advanced Plus | 00 | 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