Identity
- Trade Name
- MyLabA70 EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Model / Reference
- 66xx EUDAMED100661020 EUDAMEDFDA UDI100661120 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056304455307 EUDAMEDFDA UDI08056304455451 EUDAMEDFDA UDI
- Basic UDI-DI
- 805630445ESA.US0000008.YG EUDAMED
- 510(k) Number
- K243253 FDA UDI
- FDA Product Code
- IYN FDA UDIITX FDA UDIIYO FDA UDIQIH 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
- 892.1550 FDA UDI892.1570 FDA UDI892.1560 FDA UDI892.2050 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
MyLabA70 by Esaote S.p.A. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805630445ESA.US0000008.YG | 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 44d31d59-870b-4f5f-bcb7-654c18972889 61 fields · synced Jul 29, 2026
- FDA UDI e99461fb-3d66-4194-887b-fd69ca23b7dc 33 fields · synced May 30, 2026
- FDA UDI 0afda3f7-bc08-4292-ac7b-2cc577363cec 33 fields · synced May 30, 2026
- EUDAMED da513eb9-330c-4f3a-a267-46f542a3e6d5 61 fields · synced Jul 29, 2026