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Ultima Dual Pressure Sensor (pes)
EUDAMEDClass I (EU MDR)
Ref 0585PESModel 0581
Identity
- Trade Name
- ULTIMA DUAL PRESSURE SENSOR (PES) EUDAMED
- Device Name
- ULTIMA PRESSURE SENSOR EUDAMED
- Model / Reference
- 0581 EUDAMED0585PES EUDAMED
Identifiers
- Primary DI / UDI-DI
- B1400585PES0 EUDAMED
- Basic UDI-DI
- ++B140PressureS3 EUDAMED
- Direct Marketing DI
- B1400585PES0 EUDAMED
- EMDN Code
- Z12100580 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ultima Dual Pressure Sensor (pes) 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 | ++B140PressureS3 | Class I | Active |
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Manufacturer
- Manufacturer
- BRAEBON Medical Corporation
- EUDAMED SRN
- CA-MF-000002190
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED d0adabbb-63c6-47a1-a553-f149adac9029 61 fields · synced Jun 18, 2026