Identity
- Trade Name
- MyLab XPro75 EUDAMED
- Model / Reference
- 6430 EUDAMED100643030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056304454423 EUDAMED
- Basic UDI-DI
- 805630445ESA.US0000007.YD EUDAMEDB-08056304454423 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 XPro75 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.US0000007.YD | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 805630445ESA.US0000007.YD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- EUDAMED SRN
- IT-MF-000019024
Sources (2)
- EUDAMED 3f239406-f0d2-48fe-bc93-08371f1d5c74 61 fields · synced Jul 17, 2026
- EUDAMED b4c1fcde-b36a-451c-9ef7-9b5bb1ef34f1 61 fields · synced Jul 17, 2026