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Kristal Sil
EUDAMEDClass I (EU MDR)
Ref MSAG01Model POLYVINYLSILOXANE TRANSPARENT BICOMPONENTRef MSAG04
by Meditaly Srl
Identity
- Trade Name
- KRISTAL SIL EUDAMEDKRISTAL SIL TIXO EUDAMED
- Device Name
- KRISTAL SIL EUDAMED
- Model / Reference
- POLYVINYLSILOXANE TRANSPARENT BICOMPONENT EUDAMEDMSAG01 EUDAMEDMSAG04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057502700114 EUDAMED08057502700039 EUDAMED
- Basic UDI-DI
- 805750270MSAG00AJ EUDAMED
- Direct Marketing DI
- 08057502700114 EUDAMED08057502700039 EUDAMED
- EMDN Code
- Q01020102 DENTAL IMPRESSION VINYLSILOXANS 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
Kristal Sil by Meditaly Srl — 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 | 805750270MSAG00AJ | Class I | Active |
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Manufacturer
- Manufacturer
- Meditaly Srl
- EUDAMED SRN
- IT-MF-000020497
Sources (2)
- EUDAMED 59c232db-63af-470a-8a4a-c9f1e891ccff 61 fields · synced Jul 18, 2026
- EUDAMED cd1aee11-f8f9-4a7c-982f-631e969efa8b 61 fields · synced May 19, 2026