Identity
- Trade Name
- G-scan MSK EUDAMED
- Model / Reference
- 100001 EUDAMED100001710 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056304455734 EUDAMED
- Basic UDI-DI
- 805630445ESA.MR0000003.Q2 EUDAMED
- EMDN Code
- Z11050101 SECTORAL TOMOGRAPHS (FOR TOMOGRAPHIC EXAMINATIONS OF THE EXTREMITIES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
G-scan MSK by Esaote S.p.A. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K110238 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K111803 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K042236 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 805630445ESA.MR0000003.Q2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- EUDAMED SRN
- IT-MF-000019024
Sources (2)
- EUDAMED 66a64662-9114-4a7c-8a22-3f97bd6eadcf 61 fields · synced Jun 19, 2026
- FDA 510(k) K110238 1 fields · synced May 18, 2026