Identity
- Trade Name
- Airflow Sensor for Medatec EUDAMED
- Device Name
- Ultima Airflow Sensor EUDAMED
- Model / Reference
- 0510 EUDAMED3009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B14030090 EUDAMED
- Basic UDI-DI
- ++B140AirflowRF EUDAMED
- Direct Marketing DI
- B14030090 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
Airflow Sensor for Medatec 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 | ++B140AirflowRF | 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 fa7800c5-454f-4731-8f53-8e1f4e357d67 61 fields · synced Sep 18, 2026