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VARIAN APPLICATOR ASSY, 25x25CM TRUEBEAM
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 886800172510(k) K111106
Identity
- Trade Name
- VARIAN APPLICATOR ASSY, 25x25CM TRUEBEAM EUDAMED
- Device Name
- Electron Applicator EUDAMED
- Model / Reference
- 886800172 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00899475002653 EUDAMED
- Basic UDI-DI
- 089947500200137PX EUDAMED
- EMDN Code
- Z11010199 LINEAR ACCELERATORS – OTHER EUDAMED
Classification
- Device Class
- Class 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
VARIAN APPLICATOR ASSY, 25x25CM TRUEBEAM by Varian Medical Systems, Inc — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123291 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K111106 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 089947500200137PX | Class I | 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 57d43b50-b49a-4371-afb0-71963284f5fd 85 fields · synced Jun 19, 2026
- FDA 510(k) K123291 1 fields · synced May 18, 2026