Identity
- Trade Name
- TrueBeam EUDAMEDVARIAN APPLICATOR ASSY, 20X20CM TRUEBEAM EUDAMED
- Device Name
- TrueBeam-TrueBeam STx-Edge and VitalBeam EUDAMEDElectron Applicator EUDAMED
- Model / Reference
- TrueBeam 4.0 EUDAMED886800171 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00858086006771 EUDAMED00899475002660 EUDAMED
- Basic UDI-DI
- 089947500200122PJ EUDAMED089947500200137PX EUDAMED
- Direct Marketing DI
- 00858086006771 EUDAMED
- EMDN Code
- Z11010103 MULTI AND HIGH ENERGY LINEAR ACCELERATORS EUDAMEDZ11010199 LINEAR ACCELERATORS – OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass I 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
Yes
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
TrueBeam 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 | 089947500200122PJ | 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 (2)
- EUDAMED d9bac2ef-c54a-4716-9502-4a3a4a54bd7f 61 fields · synced Jul 8, 2026
- EUDAMED 2fc86a9f-b582-40be-8c71-305681199439 61 fields · synced May 17, 2026