Identity
- Trade Name
- Seal·it EUDAMEDSeal EUDAMED
- Device Name
- Seal·it EUDAMEDSeal it EUDAMED
- Model / Reference
- #821602 EUDAMEDΡ609 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809262954425 EUDAMED08809911112367 EUDAMED
- Basic UDI-DI
- B-08809262954425 EUDAMEDB-08809911112367 EUDAMED880926295SI3A EUDAMED
- Direct Marketing DI
- 08809262954425 EUDAMED08809911112367 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMEDNetherlands 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
Seal·it 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-08809262954425 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08809262954425 | 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 (4)
- EUDAMED 9a2137a3-9ca3-4326-b447-7d477eb85c3e 61 fields · synced Jul 21, 2026
- EUDAMED 01013519-e602-46b1-bfad-62f4a62209a9 61 fields · synced Jun 19, 2026
- EUDAMED a95e5ad8-25a2-4cb3-bdea-1670b582d5b1 61 fields · synced Jul 11, 2026
- EUDAMED 270b6c86-e62d-472e-b3c2-03af8cb1455f 61 fields · synced Jul 21, 2026