Identity
- Trade Name
- KROMOPAN SIL light body (2x50ml) - FAST SET EUDAMED
- Device Name
- GHENESYL silicone-A putty soft NORMAL SET (2x300ml) EUDAMED
- Model / Reference
- KRS550 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18016200021713 EUDAMED
- Basic UDI-DI
- 8016200DEIMSA001NY EUDAMED
- EMDN Code
- Q01020104 DENTAL IMPRESSION SILICONES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
KROMOPAN SIL light body (2x50ml) - FAST SET by Lascod S.p.a. (laboratori Scientifici Odontoiatria) — Class I — MDR — listed in EUDAMED
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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 | 8016200DEIMSA001NY | Class I | Active |
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Manufacturer
- Manufacturer
- Lascod S.p.a. (laboratori Scientifici Odontoiatria)
- EUDAMED SRN
- IT-MF-000030743
Sources (1)
- EUDAMED 11058dfa-153f-42fd-8537-6309761a8b6b 61 fields · synced Oct 7, 2026