Identity
- Trade Name
- XENO-360 EUDAMED
- Device Name
- ZEN-2090 Turbo (XENO-360) EUDAMED
- Model / Reference
- 111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809244060359 EUDAMED
- Basic UDI-DI
- 880924406ZEN2090QJ EUDAMED
- EMDN Code
- Z11039009 FLUOROSCOPY DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Xeno-360 by Genoray 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 | 880924406ZEN2090QJ | Class IIb | Active |
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Manufacturer
- Manufacturer
- GENORAY CO., Ltd.
- EUDAMED SRN
- KR-MF-000021014
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 75c07e73-bbb8-4844-9402-578895447407 61 fields · synced Jun 18, 2026