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PT1 Low Gain/Hi Pressure Kit for Alice
EUDAMEDClass I (EU MDR)
Ref 0580AModel 0580
Identity
- Trade Name
- PT1 Low Gain/Hi Pressure Kit for Alice EUDAMED
- Device Name
- Pressure Transducer Kit EUDAMED
- Model / Reference
- 0580 EUDAMED0580A EUDAMED
Identifiers
- Primary DI / UDI-DI
- B1400580A1 EUDAMED
- Basic UDI-DI
- ++B140PressureKit43 EUDAMED
- EMDN Code
- Z12100580 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
PT1 Low Gain/Hi Pressure Kit for Alice by Braebon Medical Corporation — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B140PressureKit43 | Class I | Active |
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Manufacturer
- Manufacturer
- BRAEBON Medical Corporation
- EUDAMED SRN
- CA-PR-000013743
Sources (1)
- EUDAMED 415b8585-abdb-4ae9-8b1b-9cfafcfeb374 61 fields · synced Oct 6, 2026