Identity
- Trade Name
- XERA EUDAMED
- Device Name
- General Radiography X-ray System EUDAMED
- Model / Reference
- GR10X-40K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683161912041 EUDAMED
- Basic UDI-DI
- B-08683161912041 EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Stationary basic diagnostic x-ray system, digital
Xera by XERA Medical Systems and Technology Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08683161912041 | Class IIb | Active |
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Manufacturer
- Manufacturer
- XERA Medical Systems and Technology Ltd.
- EUDAMED SRN
- TR-MF-000022581
Sources (1)
- EUDAMED f8f4ae52-e675-4ca0-8768-e82fd5806720 61 fields · synced Jun 19, 2026