Identity
- Trade Name
- F1 Arcus EUDAMED
- Device Name
- Dental Treatment System Fimet EUDAMED
- Model / Reference
- 0140 EUDAMEDF1 Arcus EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06429810585042 EUDAMED
- Basic UDI-DI
- 6429810585dentalsystem5A EUDAMEDB-06429810585042 EUDAMED
- Direct Marketing DI
- 06429810585042 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
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: Dental delivery system
F1 Arcus by Fimet Oy — Class IIa — MDD, 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/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6429810585dentalsystem5A | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6429810585dentalsystem5A | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fimet Oy
- EUDAMED SRN
- FI-MF-000006831
Sources (2)
- EUDAMED 7381b573-c0a3-4d1e-9b20-f8d58eb6c42e 61 fields · synced Jun 18, 2026
- EUDAMED daff4005-8896-4f57-b3a9-b54a4243f2eb 61 fields · synced May 18, 2026