Identity
- Trade Name
- Scan eXam™ EUDAMEDScan eXam FDA UDI
- Generic Name
- Radiography digital imaging scanner FDA UDI
- Device Name
- Scan eXam™ EUDAMED
- Model / Reference
- eXam5 EUDAMED900467/901009-PTU EUDAMEDeXam5-1 FDA UDI
Identifiers
- Catalog Number
- 900467 FDA UDI
- Primary DI / UDI-DI
- 06430035872503 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06430035872503 EUDAMED
- 510(k) Number
- K041050 FDA UDI
- FDA Product Code
- MQB FDA UDI
- EMDN Code
- Z1103040102 EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY EUDAMED
- GMDN Term
- Radiography digital imaging scanner FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- 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
No
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
Category: Dental digital imaging sensor, intraoral
Scan eXam™ by PaloDEx Group Oy — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-06430035872503 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- PaloDEx Group Oy
- EUDAMED SRN
- FI-MF-000004943
Sources (2)
- EUDAMED 69825caf-fd3e-463f-bba1-1ac630db2828 61 fields · synced Jun 19, 2026
- FDA UDI 09a8bead-474f-4a73-9574-11dd98bbf6e5 35 fields · synced May 30, 2026