Identity
- Trade Name
- DELUXE PUTTY SOFT NORMAL SET (2x300ml) EUDAMED
- Device Name
- GHENESYL silicone-A putty soft NORMAL SET (2x300ml) EUDAMED
- Model / Reference
- 902097 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18016200022154 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
DELUXE PUTTY SOFT NORMAL SET (2x300ml) by Lascod S.p.a. (laboratori Scientifici Odontoiatria) — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Silicone dental impression material.
- Defend — Young Innovations, Inc. · Class II
- UPPER IMPRESSION TRAY (S) — Dental Expert · Class I
- Katalysator Paste 35 ml — DETAX GmbH & Co. KG · Class IIa
- Bonasil A+ Regular (FS) 50ml x 32 — DMP Dental Industry S.A. · Class I
- BISSNEHMEWACHS GELB (weich) — Gebdi Dental-Products GmbH · Class I
- Polysil Multipurpose Regular Set — Scican GmbH · Class II
- 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 | 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 4ec6f771-e0e5-41c4-beed-f7e4a725e092 61 fields · synced Jun 19, 2026