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Medental Pit and Fissure Sealant Self-Cure
EUDAMEDClass IIa (EU MDR)
Ref 0PT693Model Pit and Fissure Sealant
Identity
- Trade Name
- Medental Pit and Fissure Sealant Self-Cure EUDAMED
- Device Name
- Pit and Fissure Sealant EUDAMED
- Model / Reference
- Pit and Fissure Sealant EUDAMED0PT693 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07502291841179 EUDAMED
- Basic UDI-DI
- 750229184269525 EUDAMED
- Direct Marketing DI
- 07502291841179 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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 composite resin
Medental Pit and Fissure Sealant Self-Cure by CONAMCO S.A. DE C.V. dba Medental — 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 | 750229184269525 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CONAMCO S.A. DE C.V. dba Medental
- EUDAMED SRN
- MX-MF-000020252
- Authorised Representative
- Ivonne Richaud ES-AR-000017547
Sources (1)
- EUDAMED 83041caa-0dd2-40c0-9328-9c78dc674b95 61 fields · synced Jun 18, 2026