Identity
- Trade Name
- GENDEX 1 VERT. BITE WING HO- EUDAMED
- Device Name
- Intraoral Positioning System EUDAMED
- Model / Reference
- 1.008.1091 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D090100810910 EUDAMED
- Basic UDI-DI
- ++D090ClassIJE EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Device sterilization/disinfection container, reusable
Gendex 1 Vert. Bite Wing Ho- by Dental Imaging Technologies Corporation — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D090ClassIJE | Class I | Active |
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Manufacturer
- Manufacturer
- Dental Imaging Technologies Corporation
- EUDAMED SRN
- US-MF-000017139
- Authorised Representative
- PaloDEx Group Oy FI-AR-000004955
Sources (1)
- EUDAMED 11c8ae41-317a-4dcb-ad26-efb847146792 61 fields · synced Jul 20, 2026