Identity
- Trade Name
- The Wedge EUDAMED
- Device Name
- PLASTIC WEDGES EUDAMED
- Model / Reference
- M01360 EUDAMEDM01363 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +E299M013600 EUDAMED+E299M013630 EUDAMED
- Basic UDI-DI
- ++E299PLASTICWEDGESXQ EUDAMED
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Liechtenstein 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
The Wedge by Polydentia SA — 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 | ++E299PLASTICWEDGESXQ | Class I | Active |
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Manufacturer
- Manufacturer
- Polydentia SA
- EUDAMED SRN
- CH-MF-000008779
- Authorised Representative
- IDD International Dental Distributors AG LI-AR-000008367
Sources (2)
- EUDAMED a94500ff-5b35-4167-b8b1-294827573a59 61 fields · synced Aug 3, 2026
- EUDAMED b4e13d47-f057-4942-b53b-140fffd68146 61 fields · synced May 18, 2026