Identity
- Trade Name
- ToDent Seal LC EUDAMED
- Device Name
- Seal·it EUDAMEDSeal it EUDAMED
- Model / Reference
- 39 25 05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809911112251 EUDAMED
- Basic UDI-DI
- 880926295SI3A EUDAMEDB-08809911112251 EUDAMED
- Direct Marketing DI
- 08809911112251 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMEDNetherlands 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 appliance fabrication material, ceramic
ToDent Seal LC by Spident — 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 | 880926295SI3A | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 880926295SI3A | 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 (2)
- EUDAMED a203cba9-c1ed-4e52-a02e-5c28cd4bfe46 61 fields · synced Jul 11, 2026
- EUDAMED 41a94896-755f-4157-8d92-b7e6e3eb8102 61 fields · synced Jul 11, 2026