Identity
- Trade Name
- ZEN-2090 Turbo EUDAMEDGenoray FDA UDI
- Generic Name
- Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- ZEN-2090 Turbo (XENO-360) EUDAMED
- Model / Reference
- 111 EUDAMEDZEN-2090 Turbo FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809244060120 EUDAMEDFDA UDI
- Basic UDI-DI
- 880924406ZEN2090QJ EUDAMED
- 510(k) Number
- K211780 FDA UDI
- FDA Product Code
- OWB FDA UDIJAA FDA UDIOXO FDA UDI
- EMDN Code
- Z11039009 FLUOROSCOPY DEVICES EUDAMED
- GMDN Term
- Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ZEN-2090 Turbo by Genoray Co., Ltd. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211780 | Class IIb | Active |
| 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 (3)
- EUDAMED 050a79b9-2023-464e-a30a-30fe452a1eb7 61 fields · synced Jun 18, 2026
- FDA UDI 7bd99bc7-cf5f-4d9a-ade8-35e20e521a33 33 fields · synced May 30, 2026
- FDA 510(k) K211780 1 fields · synced May 18, 2026