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MyLabX8 eXP
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 100645010Model 6450Ref 100645021
Identity
- Trade Name
- MyLabX8 eXP EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Model / Reference
- 6450 EUDAMED100645010 EUDAMEDFDA UDI100645021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056304454126 EUDAMEDFDA UDI08056304454140 EUDAMED
- Basic UDI-DI
- 805630445ESA.US0000004.Y4 EUDAMEDB-08056304454140 EUDAMEDB-08056304454126 EUDAMED
- FDA Product Code
- ITX FDA UDIIYN FDA UDIIYO FDA UDI
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1550 FDA UDI892.1560 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MyLabX8 eXP by Esaote S.p.A. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| 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 |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- EUDAMED SRN
- IT-MF-000019024
Sources (4)
- EUDAMED ed3dbb19-be96-4869-8bc1-b755349b290e 61 fields · synced Jun 20, 2026
- EUDAMED 8dba8897-4c0d-4b02-a811-674e7aac6724 61 fields · synced May 17, 2026
- EUDAMED 61bc9a40-fb9a-4ff9-9242-82deb4c113d6 61 fields · synced May 19, 2026
- FDA UDI 3f1a787d-8efb-4b81-92cb-4d4d3187e13a 32 fields · synced May 30, 2026