Identity
- Trade Name
- FD-5000 EUDAMED
- Device Name
- FD-5000 EUDAMED
- Model / Reference
- FD-5000 EUDAMED02,21,51,52 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FD-5000CM EUDAMED
- Basic UDI-DI
- B-FD-5000CM EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS 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
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-5000 by Finndent Oy — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental delivery system.
- Dental Unit — Lifedent (Zhuhai) Co., Ltd. · Class IIa
- V8 TOUCH — VITALI S.R.L. · Class IIa
- Forest — Ls Enterprises, Inc. · Class I
- Forest — Ls Enterprises, Inc. · Class I
- TY-830 — Foshan Toye Dental Equipment Co., Ltd · Class I
- Forest — Ls Enterprises, Inc. · Class I
- A5 SINGLE CART — CEFLA s.c. · Class IIa
- Forest — Ls Enterprises, Inc. · Class I
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-5000CM | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Finndent Oy
- EUDAMED SRN
- FI-MF-000000504
Sources (1)
- EUDAMED a4feea59-ed96-4da3-baa7-3b0e30ba4e3f 61 fields · synced May 23, 2026