Identity
- Trade Name
- ZEN-2090Pro(ZEN-CX2090, ZEN-2090 Turbo, XENO-360) EUDAMEDGenoray FDA UDI
- Generic Name
- Portable general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- ZEN-2090Pro(ZEN-CX2090, ZEN-2090 Turbo, XENO-360) EUDAMED
- Model / Reference
- 111 EUDAMEDZEN-2090 Pro FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809244060021 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809244060021 EUDAMED
- 510(k) Number
- K091918 FDA UDI
- FDA Product Code
- OXO FDA UDIJAA FDA UDI
- EMDN Code
- Z11039009 FLUOROSCOPY DEVICES EUDAMED
- GMDN Term
- Portable general-purpose fluoroscopic x-ray system, digital FDA UDI
- Models / Variants
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- Market of Registration
- Poland 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
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
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-2090Pro (ZEN-CX2090 +2 more) by Genoray Co., Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — 3 models — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809244060021 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GENORAY CO., Ltd.
- EUDAMED SRN
- KR-MF-000021014
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED df607772-3279-462a-9b72-635eaf71854b 61 fields · synced Jul 26, 2026
- FDA UDI f2afe5f3-1f05-48a4-8e11-c87619c783d6 33 fields · synced May 30, 2026