Identity
- Trade Name
- MB5 Basic EUDAMED
- Device Name
- MB5 Basic EUDAMED
- Model / Reference
- 471013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08015662710138 EUDAMED
- Basic UDI-DI
- 8015662MB5BASICM3 EUDAMED
- EMDN Code
- R03010380 AEROSOL THERAPY SYSTEMS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
The MB5 Basic medical device is a Class IIa medical gas system designed for anesthesia applications, offering precise control over oxygen and air flow. This reliable system features an integral gas mixer and can be integrated into various operating room settings.
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 | 8015662MB5BASICM3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Air Liquide Medical Systems S.r.l.
- EUDAMED SRN
- IT-MF-000015627
Sources (1)
- EUDAMED 09d6dff4-4f93-4079-a566-6879863ca68e 61 fields · synced Jun 26, 2026