Identity
- Trade Name
- MyLabX9 Pro EUDAMED
- Model / Reference
- 6440 EUDAMED100644016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056304454805 EUDAMED
- Basic UDI-DI
- B-08056304454805 EUDAMED805630445ESA.US0000001.XT 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
MyLabX9 Pro by Esaote S.p.A. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08056304454805 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08056304454805 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- EUDAMED SRN
- IT-MF-000019024
Sources (2)
- EUDAMED 4fa28ebf-0c99-408b-8992-305021221c86 61 fields · synced Jul 10, 2026
- EUDAMED 837136fa-49e9-49db-93da-fb69f5bd5254 61 fields · synced May 18, 2026