Identity
- Trade Name
- Gingiva Mask Model G2.0-P EUDAMED
- Device Name
- Gingiva Mask EUDAMED
- Model / Reference
- Model G2.0-P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975902950156 EUDAMED
- Basic UDI-DI
- 697590295RXT04WX 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
Gingiva Mask Model G2.0-P 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 | 697590295RXT04WX | 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 a6db983c-316d-4352-b9f4-2d06dcea9ca4 61 fields · synced Jul 29, 2026