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PureFlow OroNasal Cannula + Filter
EUDAMEDClass I (EU MDR)
Ref 8597Ref 0597Ref 0596Ref 8596
Identity
- Trade Name
- PureFlow OroNasal Cannula + Filter EUDAMEDPureFlow OroNasal Cannula EUDAMED
- Device Name
- Airflow Cannula EUDAMED
- Model / Reference
- 8597 EUDAMED0597 EUDAMED0596 EUDAMED8596 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B14085970 EUDAMEDB14005970 EUDAMEDB14005960 EUDAMEDB14085960 EUDAMED
- Basic UDI-DI
- ++B140CannulaPD 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
PureFlow OroNasal Cannula + Filter 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 | ++B140CannulaPD | 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 (4)
- EUDAMED eef7d317-bc96-484c-9682-640539fff3b7 61 fields · synced Oct 6, 2026
- EUDAMED 8f8dd0da-e972-44ac-adb5-e3e30ba0cc6c 61 fields · synced May 17, 2026
- EUDAMED 3c032ace-3425-4cfa-a920-2879b508f789 61 fields · synced May 18, 2026
- EUDAMED 81babdd5-f3d8-454d-906a-96b3abe3afd7 61 fields · synced May 18, 2026