Identity
- Trade Name
- PROTASIL Thixo 50/50 EUDAMED
- Device Name
- Pâte à empreinte silicone polyaddition EUDAMED
- Model / Reference
- SISI302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760430760000 EUDAMED
- Basic UDI-DI
- 376043076F730-30KN EUDAMED
- EMDN Code
- Q01020104 DENTAL IMPRESSION SILICONES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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: Silicone dental impression material
PROTASIL Thixo 50/50 by Prevent Transformation — Class I — 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 | 376043076F730-30KN | Class I | Active |
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Manufacturer
- Manufacturer
- Prevent Transformation
- EUDAMED SRN
- FR-MF-000047443
Sources (1)
- EUDAMED fbd6fa75-af20-4a85-b75d-d2777c530d9f 61 fields · synced Jun 19, 2026