Identity
- Trade Name
- Head Adjuster EUDAMEDAlignRT Plus FDA UDI
- Generic Name
- Radiological video camera patient positioning/tracking system FDA UDI
- Device Name
- Head Adjuster EUDAMED
- Model / Reference
- 05056190500047 EUDAMEDHead Adjuster FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056190500047 EUDAMEDFDA UDI
- Basic UDI-DI
- 5056190501006UD EUDAMED
- Direct Marketing DI
- 05056190500047 EUDAMED
- 510(k) Number
- K203387 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
- Northern Ireland 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
Head Adjuster 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 | 5056190501006UD | 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 148e3c1f-c42c-44e3-9892-b3e224fd287a 61 fields · synced Jul 17, 2026
- FDA UDI da3ba9b2-4ed6-4d04-af30-8cd56f3468d5 34 fields · synced May 30, 2026