Identity
- Trade Name
- MyLab 9 EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Model / Reference
- 6440 EUDAMED100644010 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056304453921 EUDAMEDFDA UDI
- Basic UDI-DI
- 805630445ESA.US0000001.XT EUDAMEDB-08056304453921 EUDAMED
- 510(k) Number
- K173291 FDA UDI
- FDA Product Code
- IYO FDA UDIIYN FDA UDIITX 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 UDI892.1550 FDA UDI892.1570 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
MyLab 9 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.US0000001.XT | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 805630445ESA.US0000001.XT | 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 (3)
- EUDAMED dbac942a-e4c7-44e5-b57f-ac505da7c62c 61 fields · synced Jul 17, 2026
- EUDAMED 61b6efef-219c-4f89-9c2c-ead189ba6a78 61 fields · synced May 19, 2026
- FDA UDI 603077a1-b3a6-4b6d-94ac-3f3f5e729841 33 fields · synced May 30, 2026