Identity
- Trade Name
- DuraCetal EUDAMED
- Device Name
- Thermoplastic denture base resin EUDAMED
- Model / Reference
- DC-DISC-B1-9820 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00842326104532 EUDAMED
- Basic UDI-DI
- 08423261ThermoplasticDR5S EUDAMED
- EMDN Code
- Q0102050102 DENTAL REBASING RESINS 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
DuraCetal by The Myerson Company Limited — 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 | 08423261ThermoplasticDR5S | Class I | Active |
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Manufacturer
- Manufacturer
- The Myerson Company Limited
- EUDAMED SRN
- TT-MF-000045141
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 9b6cde8e-6703-460b-a609-86fca64a3db2 61 fields · synced Jun 19, 2026