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Magnifico Open
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 100009900Model 100009510(k) K251901
Identity
- Trade Name
- Magnifico Open EUDAMEDFDA UDI
- Generic Name
- Extremity MRI system, permanent magnet FDA UDI
- Model / Reference
- 100009 EUDAMED100009900 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056304454737 EUDAMEDFDA UDI
- Basic UDI-DI
- 805630445ESA.MR0000002.PX EUDAMED
- 510(k) Number
- K212419 FDA UDI
- FDA Product Code
- LNH 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 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
Magnifico Open by Esaote S.p.A. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
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 | K251901 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 805630445ESA.MR0000002.PX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- EUDAMED SRN
- IT-MF-000019024
- FDA Applicant
- Esaote, S.p.A.
Sources (3)
- EUDAMED 9a2651b0-347f-4c2e-a9e3-bd8cfde14421 85 fields · synced Jun 18, 2026
- FDA UDI a095b550-acc9-4bbe-89f5-21bf6d023623 33 fields · synced May 30, 2026
- FDA 510(k) K251901 1 fields · synced May 18, 2026