Identity
- Trade Name
- MapRT EUDAMED
- Device Name
- MapRT EUDAMED
- Model / Reference
- MapRT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056190500924 EUDAMED
- Basic UDI-DI
- 5056190500764VP EUDAMED
- Direct Marketing DI
- 05056190500924 EUDAMED
- EMDN Code
- Z11019099 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIb 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
MapRT by Vision RT Ltd. — Class IIb — 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
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243301 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K231185 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 5056190500764VP | Class IIb | Active |
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Manufacturer
- Manufacturer
- Vision RT Ltd.
- EUDAMED SRN
- GB-MF-000010499
- FDA Applicant
- Vision Rt, Ltd.
- Authorised Representative
- Oticon A/S DK-AR-000006135
Sources (2)
- EUDAMED 42bebde0-190d-4a41-b6f3-b4aeebb00306 85 fields · synced Jun 18, 2026
- FDA 510(k) K243301 1 fields · synced May 18, 2026