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Glossy Coat Model GCH1.0-R
EUDAMEDClass I (EU MDR)
Ref Model GCH1.0-RModel Model GCH1.0-T, Model GCH1.0-DP, Model GCH1.0-P, Model GCH1.0-LP, Model GCH1.0-R, Model GCS1.0-T, Model CA1.0-T
Identity
- Trade Name
- Glossy Coat Model GCH1.0-R EUDAMED
- Device Name
- Glossy Coat EUDAMED
- Model / Reference
- Model GCH1.0-T, Model GCH1.0-DP, Model GCH1.0-P, Model GCH1.0-LP, Model GCH1.0-R, Model GCS1.0-T, Model CA1.0-T EUDAMEDModel GCH1.0-R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975902950538 EUDAMED
- Basic UDI-DI
- 697590295RXT13WY EUDAMED
- EMDN Code
- Q0102050199 DENTISTRY RESINS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Glossy Coat Model GCH1.0-R by Riton 3D 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 | 697590295RXT13WY | Class I | Active |
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Manufacturer
- Manufacturer
- Riton 3D Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000044171
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 72445146-1fc7-4d64-abc8-ac5a3a1d14aa 61 fields · synced Jul 9, 2026