Identity
- Trade Name
- Root Canal Sealer EUDAMED
- Device Name
- Root Canal Sealer EUDAMED
- Model / Reference
- Root Canal Sealer 16g EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806383591652 EUDAMED
- Basic UDI-DI
- B-08806383591652 EUDAMED
- EMDN Code
- Q01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Root Canal Sealer by Diadent Group International — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08806383591652 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Diadent Group International
- EUDAMED SRN
- KR-MF-000023806
- Authorised Representative
- Diadent Europe B.V. NL-AR-000012597
Sources (1)
- EUDAMED 500ae4ed-01e8-4136-bb3b-3d8411b60173 61 fields · synced Jun 18, 2026