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Medical Electron Linear Accelerator
EUDAMEDClass IIb (EU MDR)
Ref XHA1400Model XHA600E、XHA1400Ref XHA600E
Identity
- Trade Name
- Medical Electron Linear Accelerator EUDAMED
- Device Name
- Medical Electron Linear Accelerator EUDAMED
- Model / Reference
- XHA600E、XHA1400 EUDAMEDXHA1400 EUDAMEDXHA600E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970614965221 EUDAMED06970614965214 EUDAMED
- Basic UDI-DI
- 697061496030001QU EUDAMED
- Direct Marketing DI
- 06970614965221 EUDAMED06970614965214 EUDAMED
- EMDN Code
- Z11010102 MEDIUM AND MULTI ENERGY LINEAR ACCELERATORS EUDAMEDZ11010101 SINGLE ENERGY LINEAR ACCELERATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Liechtenstein EUDAMEDGermany 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
Medical Electron Linear Accelerator by Shinva Medical Instrument Co., Ltd. — 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 | 697061496030001QU | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shinva Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000009856
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (2)
- EUDAMED 624bad64-3731-491e-81a3-6072cb5cf1a7 61 fields · synced Jul 8, 2026
- EUDAMED 982d165a-d880-4e31-b237-ff6e2cc2fabc 61 fields · synced May 19, 2026