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Dual Pressure Sensor Safety Filter + Adapter
EUDAMEDClass I (EU MDR)
Ref 0583PESModel 0583
Identity
- Trade Name
- Dual Pressure Sensor Safety Filter + Adapter EUDAMED
- Device Name
- Ultima Pressure Sensor Hydrophobic Filter EUDAMED
- Model / Reference
- 0583 EUDAMED0583PES EUDAMED
Identifiers
- Primary DI / UDI-DI
- B1400583PES0 EUDAMED
- Basic UDI-DI
- ++B140FilterJ2 EUDAMED
- EMDN Code
- Z12100585 POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Dual Pressure Sensor Safety Filter + Adapter 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 | ++B140FilterJ2 | 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 a9f9daa1-3281-4dfb-920c-ebb5be78493a 61 fields · synced Jun 20, 2026