Identity
- Trade Name
- MyLabA500 AI EUDAMED
- Model / Reference
- 66xx EUDAMED100661130 EUDAMED100661030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056304455468 EUDAMED08056304455406 EUDAMED
- Basic UDI-DI
- 805630445ESA.US0000008.YG 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
MyLabA500 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.US0000008.YG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- EUDAMED SRN
- IT-MF-000019024
Sources (2)
- EUDAMED 926ab1da-baab-4aec-b089-7e7d42d6650c 61 fields · synced Jul 12, 2026
- EUDAMED ab18712d-56f7-4631-bb5e-c81059020eee 61 fields · synced May 17, 2026