Identity
- Trade Name
- MyLabX8 eHD EUDAMED
- Model / Reference
- 6450 EUDAMED100645011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056304454959 EUDAMED
- Basic UDI-DI
- 805630445ESA.US0000004.Y4 EUDAMEDB-08056304454959 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
MyLabX8 eHD 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 8b9e4788-f5ba-4e1b-acfa-047546c6cc2e 61 fields · synced Jul 30, 2026
- EUDAMED 929571fa-39f9-4e6b-8750-80b727b4d04b 61 fields · synced May 19, 2026