Identity
- Trade Name
- MyLab XPro80 EUDAMED
- Model / Reference
- 6450 EUDAMED100645030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056304454218 EUDAMED
- Basic UDI-DI
- 805630445ESA.US0000004.Y4 EUDAMEDB-08056304454218 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
MyLab XPro80 by Esaote S.p.A. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 805630445ESA.US0000004.Y4 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 805630445ESA.US0000004.Y4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- EUDAMED SRN
- IT-MF-000019024
Sources (2)
- EUDAMED abec96c9-1001-47dd-b476-85728d962c62 61 fields · synced Jun 20, 2026
- EUDAMED 19fa799f-4985-41f4-97e1-d9d814f6927a 61 fields · synced May 17, 2026