Identity
- Trade Name
- G-scan Open EUDAMEDFDA UDI
- Generic Name
- Extremity MRI system, permanent magnet FDA UDI
- Model / Reference
- 100001 EUDAMED100001700 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056304455727 EUDAMEDFDA UDI
- Basic UDI-DI
- 805630445ESA.MR0000004.Q5 EUDAMED
- FDA Product Code
- MOS FDA UDILLZ FDA UDILNH FDA UDI
- EMDN Code
- Z11050102 OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T EUDAMED
- GMDN Term
- Extremity MRI system, permanent magnet FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 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
G-scan Open 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.MR0000004.Q5 | 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 3738f20f-7897-46df-ae7a-83cdc12951d4 61 fields · synced Jun 17, 2026
- FDA UDI 06070107-ef68-4706-bee5-471232cebe47 32 fields · synced May 30, 2026