Identity
- Trade Name
- Eposeal EUDAMED
- Device Name
- Eposeal EUDAMED
- Model / Reference
- Sealers EUDAMED40013-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D9674001310% EUDAMED
- Basic UDI-DI
- B-+D9674001310% EUDAMED
- EMDN Code
- Q01010202 ROOT CANAL FILLING DENTAL CEMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Cyprus EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
Category: Calcium hydroxide dental cement
Eposeal by Prevest Denpro Limited — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Calcium hydroxide dental cement.
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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-+D9674001310% | Class IIa | Active |
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Manufacturer
- Manufacturer
- Prevest Denpro Limited
- EUDAMED SRN
- IN-MF-000011546
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED d8e7b1d4-4d07-46fc-b21f-2adbda96e09d 61 fields · synced Jul 10, 2026