Identity
- Trade Name
- AVa EUDAMED
- Device Name
- SteroPHAN EUDAMED
- Model / Reference
- 1255 EUDAMED1280 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060608881185 EUDAMED
- Basic UDI-DI
- 506060888PHSTPPHUU EUDAMED
- EMDN Code
- Z11010180 LINEAR ACCELERATORS - HARDWARE ACCESSORIES 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
Category: Accelerator system quality assurance device
AVa by Sun Nuclear Corporation — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 506060888PHSTPPHUU | Class I | Active |
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Manufacturer
- Manufacturer
- Sun Nuclear Corporation
- EUDAMED SRN
- US-MF-000020245
- Authorised Representative
- Sun Nuclear GmbH DE-AR-000012933
Sources (1)
- EUDAMED 588ed782-49fe-4796-9607-1e6ec582fcc1 61 fields · synced Jul 27, 2026