Identity
- Device Name
- OVER E EUDAMED
- Model / Reference
- DEV0.01E EUDAMED
Identifiers
- Primary DI / UDI-DI
- D121DEV001E0 EUDAMED
- Basic UDI-DI
- B-D121DEV001E0 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Dental delivery system
Over E by Tecnomed Italia Srl — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-D121DEV001E0 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Tecnomed Italia Srl
- EUDAMED SRN
- IT-MF-000048764
Sources (1)
- EUDAMED d14c7025-eec3-4054-8355-00cd897bb9ee 61 fields · synced Jun 19, 2026