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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 37 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BiPAP A40 | BiPAP A40 Ventilator, CN | FDA UDI | Class II | Active |
| Af531 | AF531 EE, Leak 1, Neb Elbow, w/4 PT Headgr, SU, Medium, US | FDA UDI | Class II | Active |
| Af541 | AF541 Discharge Kit, Small Medium Capstrap | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro w/ Auto-Trial and Humidifier, AR | FDA UDI | Class II | Active |
| Amara View | Amara View Mask with Headgear, Medium, US | FDA UDI | Class II | Active |
| Wisp | Wisp Mask, Petite, Clear Frame, with Headgear, INTL | FDA UDI | Class II | Active |
| DreamStation | DreamStation Heated Humidifier, IT | FDA UDI | Class II | Active |
| DreamMapper | 2.7 | FDA UDI | Class II | Active |
| DreamStation Go | 01 | FDA UDI | Class II | Active |
| BiPAP A40 | ITX3100T21 | FDA UDI | Class II | Active |
| Contour Deluxe | Contour Deluxe Mask w/Headgear, SPU, Petite, KR | FDA UDI | Class II | Active |
| Alice 6 | Alice 6 LDE Headbox, China | FDA UDI | Class II | Unknown |
| Dorma 200 | Dorma 200, CA | FDA UDI | Class II | Active |
| ezRIP | ezRIP, Thorax, Harwin, 26 inch | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro BiFlex, System One 60 Series, CN | FDA UDI | Class II | Unknown |
| DreamMapper Mobile App Android (EMEA) | 2.13 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AVAPS 30 AE w/Humid w/H Tube, AU | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP autoSV, ES | FDA UDI | Class II | Active |
| Circuits | Disposable Pediatric Heated Passive Circuit, NO | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Auto CPAP with Bluetooth, IN | FDA UDI | Class II | Unknown |
| Pico | 00 | FDA UDI | Class II | Active |
| Easylife | EasyLife Mask w/Headgear, Medium Wide, International | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AVAPS 30 w/Heated Humidifier, AAM EU | FDA UDI | Class II | Active |
| Circuits | Circuit, Disposable, 22mm, Adult, Non-Heated Passive | FDA UDI | Class II | Active |
| REMstar SE | REMstar SE with SD Slot, US | FDA UDI | Class II | Active |
| Amara View | Amara View Mask with Headgear, FitPack | FDA UDI | Class II | Active |
| Af531 | AF531 Mask w/SE, 4 PT Headgear, SU, Medium, CN | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Cellular Modem with Oximetry, US | FDA UDI | Class I | Unknown |
| DreamWear | 1137469 | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro BiFlex, w/Humidifier, System One 60 Series, SE | FDA UDI | Class II | Active |
| Omnilab Direct | OmniLab Direct, Web Software - 2 | FDA UDI | Class II | Active |
| Adult Vel.strap Kit 1.5", Size 2 | VELCRO STRAP | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AVAPS30, SP | FDA UDI | Class II | Active |
| Nebulizing Elbow | SE Nebulizing Elbow Kit, Single, CN | FDA UDI | Class II | Unknown |
| Alice 6 | Alice 6 Base Station, LDx, Brazil | FDA UDI | Class II | Unknown |
| Amara View | Amara View Mask with Headgear, Large, INTL | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro with Humidifier, with Cell, US | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class I | Active |
| Pn841 | PN841 Mask, JPN, Child Small, Leak 3, Single Use | FDA UDI | Class II | Unknown |
| BiPAP AVAPS | 00 | FDA UDI | Class II | Active |
| Contour Deluxe | Contour Deluxe Mask and Headgear, SPU, Petite, US/Intl | FDA UDI | Class II | Active |
| A Series Heated Humidifier | 00 | FDA UDI | Class II | Active |
| BiPAP | SPX3100S19 | FDA UDI | Class II | Active |
| Pico | 00 | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A-Flex w/HT Humid System One 60 Series, US | FDA UDI | Class II | Unknown |
| Care Orchestrator Denmark | 1.13 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP with Humidifier, ZA | FDA UDI | Class II | Active |
| Af531 | AF531 Mask w/SE, w/Reduced Size 4 PT Headgear, SU, Medium | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Auto BiPAP w/Cell, AHP | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP autoSV, Postponement | 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