Identity
- Trade Name
- FLUOROSEAL EUDAMED
- Device Name
- Base·it EUDAMED
- Model / Reference
- #816103DFS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809911114545 EUDAMED
- Basic UDI-DI
- 880926295BIZL EUDAMED
- Direct Marketing DI
- 08809911114545 EUDAMED
- EMDN Code
- Q0101010201 DENTAL BASE CEMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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 composite resin
Fluoroseal by Spident — Class IIa — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880926295BIZL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Spident
- EUDAMED SRN
- KR-MF-000008691
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 7c2991f5-fcd4-448c-8bb0-930feb3b1bea 61 fields · synced Jun 18, 2026