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Temporary Model Model T1.0-A3.5
EUDAMEDClass I (EU MDR)
Ref Model T1.0-A3.5Model Model T1.0-A1, Model T1.0-A2, Model T1.0-A3, Model T1.0-A3.5, Model T1.0-A4, Model T1.0-B1, Model T1.0-B2, Model T1.0-B3
Identity
- Trade Name
- Temporary Model Model T1.0-A3.5 EUDAMED
- Device Name
- Temporary Model EUDAMED
- Model / Reference
- Model T1.0-A1, Model T1.0-A2, Model T1.0-A3, Model T1.0-A3.5, Model T1.0-A4, Model T1.0-B1, Model T1.0-B2, Model T1.0-B3 EUDAMEDModel T1.0-A3.5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975902950439 EUDAMED
- Basic UDI-DI
- 697590295RXT08X7 EUDAMED
- EMDN Code
- Q0102050101 TEMPORARY TEETH RESINS 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
Category: Dental appliance fabrication material, resin
Temporary Model Model T1.0-A3.5 by Riton 3D Technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697590295RXT08X7 | 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 f57532e2-9875-41f0-b4c2-cc3980534221 61 fields · synced Jul 15, 2026