Identity
- Trade Name
- IDOT IP SET S1 X 6 OPTIME TYPE EUDAMEDImaging Plates FDA UDI
- Generic Name
- Digital imaging storage phosphor screen FDA UDI
- Device Name
- Imaging plates EUDAMEDIDOT IP-SET 1X6 DT-1 FDA UDI
- Model / Reference
- 901253-PTU EUDAMED900441 FDA UDI
- Description
- IDOT IP-SET 1X6 DT-1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430035875047 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06430035875047 EUDAMED
- FDA Product Code
- IWZ FDA UDI
- EMDN Code
- Z1103040102 EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY EUDAMED
- GMDN Term
- Digital imaging storage phosphor screen FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1840 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental digital imaging sensor, intraoral
Idot Ip Set S1 X 6 Optime Type 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-06430035875047 | 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 35fe6e8e-f7ae-4385-998a-858d21917784 61 fields · synced Aug 2, 2026
- FDA UDI a667b28d-18f1-4486-9dcf-d9b290ed20c9 33 fields · synced May 30, 2026