Identity
- Trade Name
- SELLADOR DE PUNTOS Y FISURAS EUDAMED
- Device Name
- Seal it EUDAMEDSeal·it EUDAMED
- Model / Reference
- 63546 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809911111759 EUDAMED
- Basic UDI-DI
- B-08809911111759 EUDAMED880926295SI3A EUDAMED
- Direct Marketing DI
- 08809911111759 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMEDBelgium 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
Sellador De Puntos Y Fisuras by Spident — Class IIa — MDR, MDD — 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08809911111759 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08809911111759 | 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 5c4147ba-4e87-4ab9-95ab-73a2b3b5e7c4 61 fields · synced Jul 27, 2026
- EUDAMED 445b321a-8531-41c0-a748-29479c71bd56 61 fields · synced Jul 27, 2026