Identity
- Trade Name
- F.I.T.T. EUDAMED
- Device Name
- FITT EUDAMED
- Model / Reference
- 61144 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08594747006330 EUDAMED
- Basic UDI-DI
- 8594747100001126 EUDAMED
- EMDN Code
- Q01020601 MOBILE DENTAL PROSTHESES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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: Partial denture
F.i.t.t. by SpofaDental a.s. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Partial denture.
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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 | 8594747100001126 | Class I | Active |
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Manufacturer
- Manufacturer
- SpofaDental a.s.
- EUDAMED SRN
- CZ-MF-000000945
Sources (1)
- EUDAMED 94cfc30c-6e9f-4d20-9a22-e153652864ba 61 fields · synced Jul 9, 2026