Identity
- Trade Name
- MyLabTwice EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Model / Reference
- 6200 EUDAMED101620000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056304450005 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08056304450005 EUDAMED
- FDA Product Code
- IYO FDA UDIITX FDA UDIIYN 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
- 892.1560 FDA UDI892.1570 FDA UDI892.1550 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
MyLabTwice by Esaote S.p.A. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08056304450005 | 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 (2)
- EUDAMED 40388928-6f46-476d-9b3a-b001f02453e6 61 fields · synced Jul 23, 2026
- FDA UDI abb33b7c-f510-4ce6-b05b-31a881473f48 32 fields · synced May 30, 2026