Identity
- Trade Name
- PAPAYA 3D Premium Plus EUDAMEDGenoray FDA UDI
- Generic Name
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
- Device Name
- PAPAYA 3D Premium Plus EUDAMED
- Model / Reference
- 705 EUDAMEDPAPAYA 3D Premium Plus FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809244060281 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809244060281 EUDAMED
- 510(k) Number
- K200469 FDA UDI
- FDA Product Code
- OAS FDA UDIMUH FDA UDI
- EMDN Code
- Z1103030102 EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL EUDAMED
- GMDN Term
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI872.1800 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
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
PAPAYA 3D Premium Plus by Genoray Co., Ltd. — Class IIb — FDA_510K, MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200469 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08809244060281 | 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 9612da42-1cc2-4990-b8db-0fd3a23d5798 61 fields · synced Jul 18, 2026
- FDA UDI 2a247190-3d3b-4f6c-877a-7f3c45e79864 33 fields · synced May 29, 2026
- FDA 510(k) K200469 1 fields · synced May 18, 2026