Identity
- Trade Name
- Cliniview™ 11 EUDAMEDCliniview 11 FDA UDI
- Generic Name
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
- Device Name
- Cliniview™ 11 EUDAMED
- Model / Reference
- 11.x EUDAMEDFDA UDI213183 EUDAMED
Identifiers
- Catalog Number
- 213183 FDA UDI
- Primary DI / UDI-DI
- 06430035872350 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06430035872350 EUDAMED
- 510(k) Number
- K092591 FDA UDI
- FDA Product Code
- MUH FDA UDI
- EMDN Code
- Z11030392 INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGY - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1800 FDA UDI
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Finland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Cliniview™ 11 by PaloDEx Group Oy — Class IIa — 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 | K162799 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06430035872350 | Class IIa | Active |
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Manufacturer
- Manufacturer
- PaloDEx Group Oy
- EUDAMED SRN
- FI-MF-000004943
Sources (3)
- EUDAMED 5cb9dd13-6b30-42aa-b607-689d9d3ced23 61 fields · synced Jul 11, 2026
- FDA UDI d36856e2-da43-4a7b-96cb-496a0bfefb23 35 fields · synced May 30, 2026
- FDA 510(k) K162799 1 fields · synced May 18, 2026