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Cavex SiliconA Injection type
EUDAMEDClass IIa (EU MDR)
Ref AS53Model Dental Impression Material, Silicone Rubber
Identity
- Trade Name
- Cavex SiliconA Injection type EUDAMED
- Device Name
- Cavex SiliconA EUDAMED
- Model / Reference
- Dental Impression Material, Silicone Rubber EUDAMEDAS53 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E241AS530 EUDAMED
- Basic UDI-DI
- ++E241AS0068 EUDAMED
- Direct Marketing DI
- E241AS530 EUDAMED
- EMDN Code
- Q01020104 DENTAL IMPRESSION SILICONES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Cavex SiliconA Injection type by Cavex Holland BV — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Cavex SiliconA & SiliconA Bite
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 | ++E241AS0068 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cavex Holland BV
- EUDAMED SRN
- NL-MF-000000423
Sources (1)
- EUDAMED c61a99e4-2969-45fb-b58a-c4c6896b7f1b 61 fields · synced Jul 17, 2026