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MyLabA750 AI
EUDAMEDClass IIa (EU MDR)
Ref 100661050Model 66xxRef 100661051Ref 100661150
Identity
- Trade Name
- MyLabA750 AI EUDAMED
- Model / Reference
- 66xx EUDAMED100661050 EUDAMED100661051 EUDAMED100661150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056304455420 EUDAMED08056304456007 EUDAMED08056304455482 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
MyLabA750 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 (3)
- EUDAMED 8bd84c39-dd9a-43f8-be02-acac97acdc7d 61 fields · synced Sep 18, 2026
- EUDAMED 827d3053-32bc-468a-ac67-72bbc7670aa4 61 fields · synced May 18, 2026
- EUDAMED fcb0f7ce-7700-45bc-8481-46ffb061d497 61 fields · synced May 19, 2026