Identity
- Trade Name
- FD-8000 EUDAMED
- Device Name
- FD-8000 EUDAMED
- Model / Reference
- FD-8000 EUDAMED26-38 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FD-8000DA EUDAMED
- Basic UDI-DI
- B-FD-8000DA EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland 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
Fd-8000 by Finndent Oy — 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-FD-8000DA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Finndent Oy
- EUDAMED SRN
- FI-MF-000000504
Sources (1)
- EUDAMED db6ca369-372b-4711-95d7-2d6332425621 61 fields · synced Jun 19, 2026