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Smart Sil
EUDAMEDClass I (EU MDR)
Ref SmartSil-Bite Registration
by Seil Global
Identity
- Trade Name
- Smart Sil EUDAMED
- Device Name
- Dental Impression Material EUDAMED
- Model / Reference
- SmartSil-Bite Registration EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800156401827 EUDAMED
- Basic UDI-DI
- 88001564SEIL04J9 EUDAMED
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Smart Sil by Seil Global — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Silicone dental impression material.
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- PERFECTO — CROWN DELTA CORP. · Class II
- Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · Class I
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 | 88001564SEIL04J9 | Class I | Active |
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Manufacturer
- Manufacturer
- Seil Global
- EUDAMED SRN
- KR-MF-000013925
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 96eeca4d-56f7-42dc-a081-67a80535aec5 61 fields · synced May 23, 2026