Identity
- Trade Name
- Halcyon EUDAMED
- Device Name
- Halcyon, Ethos Radiotherapy System EUDAMED
- Model / Reference
- Halcyon 5.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00857235006082 EUDAMED
- Basic UDI-DI
- 089947500200108PQ EUDAMED
- EMDN Code
- Z11010101 SINGLE ENERGY LINEAR ACCELERATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands 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
Halcyon by Varian Medical Systems, Inc. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 089947500200108PQ | Class IIb | Active |
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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 (1)
- EUDAMED fb8c121d-d80c-4759-9783-005fdd5fff9b 61 fields · synced Oct 6, 2026