Identity
- Trade Name
- HIGH VOLTAGE X-RAY GENERATORS EUDAMED
- Device Name
- HIGH VOLTAGE X-RAY GENERATORS EUDAMED
- Model / Reference
- DTXR-50、DTXR-65 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976512680808 EUDAMED
- Basic UDI-DI
- 6976512685065DT EUDAMED
- Direct Marketing DI
- 06976512680808 EUDAMED
- EMDN Code
- Z11039011 HIGH VOLTAGE X-RAY GENERATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye 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: Diagnostic x-ray system generator, stationary
High Voltage X-Ray Generators by Liaoning DTKL Technology Co., Ltd — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Diagnostic x-ray system generator, stationary.
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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 | 6976512685065DT | Class IIb | Active |
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Manufacturer
- Manufacturer
- Liaoning DTKL Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000033792
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED ed5bf4df-55d1-4e57-a836-b5e8b3e7df0f 61 fields · synced Jul 13, 2026