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Temporary Model Model T1.0-B1
EUDAMEDClass I (EU MDR)
Ref Model T1.0-B1Model 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-B1 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-B1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975902950446 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
Temporary Model Model T1.0-B1 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 | 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 f5c0831e-bce5-4eff-b36d-83c8fc75485e 61 fields · synced Jul 28, 2026