Identity
- Trade Name
- EDGE EUDAMED
- Device Name
- TrueBeam-TrueBeam STx-Edge and VitalBeam EUDAMED
- Model / Reference
- EDGE 4.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00858086006795 EUDAMED
- Basic UDI-DI
- 089947500200122PJ EUDAMED
- Direct Marketing DI
- 00858086006795 EUDAMED
- EMDN Code
- Z11010103 MULTI AND HIGH 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Edge 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 (1)
- EUDAMED 18f2152e-d5c6-4e08-b8d0-c9ec923459d3 61 fields · synced Jun 9, 2026