Visual Coaching Device
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Visual Coaching Device EUDAMEDVisual Coaching Device (VCD) FDA UDI
- Generic Name
- Real-time position management respiratory gating system, optical FDA UDI
- Device Name
- Visual Coaching Device EUDAMED
- Model / Reference
- Visual Coaching Device 3.0 EUDAMED3.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856100006158 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500200155PZ EUDAMED
- Direct Marketing DI
- 00856100006158 EUDAMED
- FDA Product Code
- IYE FDA UDIJAK FDA UDI
- EMDN Code
- Z11019080 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Real-time position management respiratory gating system, optical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI892.1750 FDA UDI
- Market of Registration
- Netherlands 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
No
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
Visual Coaching Device by Varian Medical Systems, Inc — 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 | 089947500200155PZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000001784
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (2)
- EUDAMED f9890d1d-c836-4b39-81e1-dbd08d2d17b6 61 fields · synced Jul 17, 2026
- FDA UDI 24b3cb3d-e05c-487f-9da3-5572b3142bc4 33 fields · synced May 29, 2026