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MyLabX90 Pro
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 100644055Model 6440Ref 100640085
Identity
- Trade Name
- MyLabX90 Pro EUDAMED
- Model / Reference
- 6440 EUDAMED100644055 EUDAMED100640085 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056304455109 EUDAMED08056304455147 EUDAMED
- Basic UDI-DI
- 805630445ESA.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
MyLabX90 Pro by Esaote S.p.A. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230179 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 805630445ESA.US0000001.XT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- EUDAMED SRN
- IT-MF-000019024
Sources (3)
- EUDAMED 7238e845-5cf8-4330-ba96-8bf2c016c7be 61 fields · synced Aug 3, 2026
- EUDAMED 595cb4b7-27cc-44cf-a1f5-4a1080361c66 61 fields · synced May 18, 2026
- FDA 510(k) K230179 1 fields · synced May 18, 2026