Identity
- Trade Name
- IRIS BY STARCK EUDAMED
- Device Name
- IRIS BY STARCK EUDAMED
- Model / Reference
- NA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03664128000082 EUDAMED
- Basic UDI-DI
- 366412836641280000820UM EUDAMED
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Iris By Starck by Scan4all — 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 | 366412836641280000820UM | Class I | Active |
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Manufacturer
- Manufacturer
- Scan4all
- EUDAMED SRN
- FR-MF-000003516
Sources (1)
- EUDAMED efa37e25-6f60-4417-ba5a-5f88f4bdce8c 61 fields · synced Jun 19, 2026