Identity
- Trade Name
- SEALITE LIQUIDE EUDAMED
- Device Name
- SEALITE REGULAR EUDAMED
- Model / Reference
- 266267 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760243000867 EUDAMED
- Basic UDI-DI
- 376024300sealiterPY EUDAMED
- EMDN Code
- Q01010202 ROOT CANAL FILLING DENTAL CEMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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: Calcium hydroxide dental cement
Sealite Liquide by Acteon Manufacturing — Class IIa — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 376024300sealiterPY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Acteon Manufacturing
- EUDAMED SRN
- FR-MF-000007556
Sources (1)
- EUDAMED ea667840-b382-4a48-b85f-90b0318ce29d 61 fields · synced Jul 14, 2026