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Splint Model HS1.0-T
EUDAMEDClass I (EU MDR)
Ref Model HS1.0-TModel Model HS1.0-T、Model SS1.0-T
Identity
- Trade Name
- Splint Model HS1.0-T EUDAMED
- Device Name
- Splint EUDAMED
- Model / Reference
- Model HS1.0-T、Model SS1.0-T EUDAMEDModel HS1.0-T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975902950408 EUDAMED
- Basic UDI-DI
- 697590295RXT07X5 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
Splint Model HS1.0-T 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 | 697590295RXT07X5 | 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 ddc7837a-d2df-4862-abae-6f5b46d56afc 61 fields · synced Jul 11, 2026