← Back to catalogue
MyLabX75 eHD
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 100643020Model 6430Ref 100643000
Identity
- Trade Name
- MyLabX75 eHD EUDAMEDMyLabX75 EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Model / Reference
- 6430 EUDAMED100643020 EUDAMED100643000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056304454409 EUDAMED08056304454386 EUDAMEDFDA UDI
- Basic UDI-DI
- 805630445ESA.US0000007.YD EUDAMEDB-08056304454409 EUDAMEDB-08056304454386 EUDAMED
- 510(k) Number
- K212021 FDA UDI
- 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
MyLabX75 eHD 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.US0000007.YD | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 805630445ESA.US0000007.YD | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Esaote S.p.A.
- EUDAMED SRN
- IT-MF-000019024
Sources (5)
- EUDAMED e025baf4-28e3-4436-af4b-52aa82857470 61 fields · synced Jul 17, 2026
- EUDAMED c52f06dc-6997-4392-bad3-38e08f68993b 61 fields · synced May 17, 2026
- EUDAMED 4d2cffe4-eb8e-4fc6-a506-069509c19913 61 fields · synced May 19, 2026
- FDA UDI ad33229d-8988-4c35-9f0b-970a7f00dbf6 33 fields · synced May 30, 2026
- EUDAMED 851a1a99-2b72-4bc7-8cee-5310b89f5dbc 61 fields · synced Jul 17, 2026