Identity
- Trade Name
- XERA EUDAMED
- Device Name
- Long Format Detector Holder EUDAMED
- Model / Reference
- XEBS-W1-LF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683161912034 EUDAMED
- Basic UDI-DI
- 8683161912XLF01DU EUDAMED
- Direct Marketing DI
- 08683161912034 EUDAMED
- EMDN Code
- Z11031180 SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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
Xera by XERA Medical Systems and Technology Ltd. — Class I — 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 | 8683161912XLF01DU | Class I | Active |
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Manufacturer
- Manufacturer
- XERA Medical Systems and Technology Ltd.
- EUDAMED SRN
- TR-MF-000022581
Sources (1)
- EUDAMED eb068f1d-4dad-4f87-a5d6-ee4b91e3b55a 61 fields · synced Jul 18, 2026