Identity
- Trade Name
- Denture Base Resin EUDAMED
- Device Name
- Denture Base Resin EUDAMED
- Model / Reference
- DB 10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978646900135 EUDAMED
- Basic UDI-DI
- 697864690DBRXX EUDAMED
- EMDN Code
- Q0102050199 DENTISTRY RESINS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Denture Base Resin by Jinhua Raychen New Material Technology Co., Ltd — 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 | 697864690DBRXX | Class I | Active |
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Manufacturer
- Manufacturer
- Jinhua Raychen New Material Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000047792
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 45a7e99b-07d7-444a-97bf-68f4db0e12ed 61 fields · synced Oct 7, 2026