Identity
- Trade Name
- MyLabE880 AI EUDAMED
- Model / Reference
- 6450E EUDAMED100645094 EUDAMED100645093 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056304456144 EUDAMED08056304456137 EUDAMED
- Basic UDI-DI
- 805630445ESA.US0000009.YK EUDAMED
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
MyLabE880 AI by Esaote S.p.A. — Class IIa — 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 | 805630445ESA.US0000009.YK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- EUDAMED SRN
- IT-MF-000019024
Sources (2)
- EUDAMED 7b0d96b5-5da9-40cb-95dd-45888ab737fc 61 fields · synced Jul 12, 2026
- EUDAMED 8515874a-feee-45f3-9f7e-be68ac0be98e 61 fields · synced May 17, 2026