Identity
- Trade Name
- KROMOPAN SIL MONO - monofase (2x50ml) EUDAMED
- Device Name
- GHENESYL silicone-A putty soft NORMAL SET (2x300ml) EUDAMED
- Model / Reference
- KRS400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18016200021805 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
KROMOPAN SIL MONO - monofase (2x50ml) by Lascod S.p.a. (laboratori Scientifici Odontoiatria) — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lascod S.p.a. (laboratori Scientifici Odontoiatria)
- EUDAMED SRN
- IT-MF-000030743
Sources (1)
- EUDAMED b0202bb8-d40a-467b-8790-da6cc64e9b5a 61 fields · synced Jun 20, 2026