Identity
- Device Name
- MR Contour DL EUDAMED
- Model / Reference
- 5986345-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00198953043387 EUDAMED
- Basic UDI-DI
- 08406821BUG0059782 EUDAMED
- EMDN Code
- Z11050192 MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- France 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
MR Contour DL by GE Healthcare — 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
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242925 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 08406821BUG0059782 | Class IIa | Active |
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Manufacturer
- Manufacturer
- GE Healthcare
- EUDAMED SRN
- US-MF-000001862
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED 95fe3f30-5fce-4d4a-a4c9-848d080893a0 61 fields · synced Jun 18, 2026
- FDA 510(k) K242925 1 fields · synced May 18, 2026