Identity
- Trade Name
- neo315 EUDAMED
- Device Name
- neo315 EUDAMED
- Model / Reference
- neo315 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 42606855900050 EUDAMED
- Basic UDI-DI
- 426068559NEO315AL EUDAMED
- EMDN Code
- Z11050104 CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Category: Full-body MRI system, superconducting magnet
neo315 by Neoscan Solutions GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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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 | K231133 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 426068559NEO315AL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Neoscan Solutions GmbH
- EUDAMED SRN
- DE-MF-000007899
Sources (2)
- EUDAMED 66441564-caa5-4036-801a-27956bf7a721 61 fields · synced Jun 19, 2026
- FDA 510(k) K231133 1 fields · synced May 18, 2026