Identity
- Trade Name
- Real-Time Coach Mk2 EUDAMEDAlignRT Plus FDA UDI
- Generic Name
- Radiological video camera patient positioning/tracking system FDA UDI
- Device Name
- Real-Time Coach EUDAMED
- Model / Reference
- 5056190500788 EUDAMEDReal Time Coach FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056190500788 EUDAMEDFDA UDI
- Basic UDI-DI
- 5056190501013UA EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11019099 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER 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
- Northern Ireland 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
Real-Time Coach Mk2 by Vision RT Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5056190501013UA | 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 70768dbc-4b31-457c-95c0-1d90a6a12b29 61 fields · synced Jul 22, 2026
- FDA UDI fd7e1959-e4c8-4e76-ae04-6237ce20f08f 33 fields · synced May 30, 2026