Dexis Vertical Hand-Held Ll-Ur
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- DEXIS VERTICAL HAND-HELD LL-UR - Rework EUDAMEDDEXIS VERTICAL HAND-HELD LL-UR FDA UDI
- Generic Name
- Dental x-ray film holder, reusable FDA UDI
- Device Name
- Intraoral Positioning System EUDAMED
- Model / Reference
- 1.013.5125 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- D090101351250 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D090ClassIJE EUDAMED
- FDA Product Code
- EGZ FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Dental x-ray film holder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.1905 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental x-ray film holder, reusable
Dexis Vertical Hand-Held Ll-Ur by Dental Imaging Technologies Corporation — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental x-ray film holder, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dental Imaging Technologies Corporation
Sources (2)
- FDA UDI 148847ac-cd32-4ddd-98fb-3c4ad361d8ac 32 fields · synced Jul 9, 2026
- EUDAMED 27cc8554-1eca-497e-830f-8c814dcd5941 61 fields · synced Jul 9, 2026