Identity
- Trade Name
- A Silicone VPS Impression Material EUDAMED
- Device Name
- SilArt Light Body 50 ml EUDAMED
- Model / Reference
- 10305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698907697755 EUDAMED
- Basic UDI-DI
- 8698907610305HZ EUDAMED
- EMDN Code
- Q01020104 DENTAL IMPRESSION SILICONES 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
A Silicone VPS Impression Material by İnci̇ Dental Tibbi̇ Malzeme San. Ve Ti̇c. Ltd. Şti̇. — 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 | 8698907610305HZ | Class I | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000029487
Sources (1)
- EUDAMED 8773578f-bfe7-4c3f-a6f9-c79e852f5699 61 fields · synced Oct 6, 2026