Calibration Cube and Levelling Plate
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Calibration Cube and Levelling Plate EUDAMEDAlignRT Plus FDA UDI
- Generic Name
- Radiological video camera patient positioning/tracking system FDA UDI
- Device Name
- Calibration Cube EUDAMEDCalibration Cube Mk2 FDA UDI
- Model / Reference
- Calibration Cube Mk2 EUDAMEDFDA UDI
- Description
- Calibration Cube Mk2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056190500863 EUDAMEDFDA UDI
- Basic UDI-DI
- 5056190501082UV EUDAMED
- Direct Marketing DI
- 05056190500863 EUDAMED
- 510(k) Number
- K212583 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11019080 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiological video camera patient positioning/tracking system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Multi-modality therapeutic radiation phantom, test object
Calibration Cube and Levelling Plate by Vision RT Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5056190501082UV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Vision RT Ltd.
- EUDAMED SRN
- GB-MF-000010499
- Authorised Representative
- Oticon A/S DK-AR-000006135
Sources (2)
- EUDAMED b92e7504-5c54-48fd-bac4-0124ec258b01 61 fields · synced Jun 19, 2026
- FDA UDI 752b96cb-3f3a-40d0-be8e-9e9061daa9c4 35 fields · synced May 30, 2026