Identity
- Trade Name
- MikroAir™ EUDAMED
- Device Name
- MIKROAIR EUDAMED
- Model / Reference
- MIKROAIR EUDAMED103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055712800013 EUDAMED
- Basic UDI-DI
- 805571280MikroAirK8 EUDAMED
- EMDN Code
- Z12011301 CLEANING AND DISINFECTION EQUIPMENT EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Surgical utensil washer/disinfector
MikroAir™ by Biodisin S.r.l — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 805571280MikroAirK8 | Class I | Active |
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Manufacturer
- Manufacturer
- Biodisin S.r.l
- EUDAMED SRN
- IT-MF-000031661
Sources (1)
- EUDAMED 648ac9b2-7445-4714-b429-73558910f884 61 fields · synced Sep 18, 2026