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Ortho Model Resin
EUDAMEDClass I (EU MDR)
Ref RF-ZJ-01-04Model RF-ZJ-01Ref RF-ZJ-01-01Ref RF-ZJ-01-03Ref RF-ZJ-01-02
Identity
- Trade Name
- Ortho Model Resin EUDAMED
- Device Name
- Ortho Model Resin EUDAMED
- Model / Reference
- RF-ZJ-01 EUDAMEDRF-ZJ-01-04 EUDAMEDRF-ZJ-01-01 EUDAMEDRF-ZJ-01-03 EUDAMEDRF-ZJ-01-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978499316015 EUDAMED06978499313014 EUDAMED06978499315018 EUDAMED06978499314011 EUDAMED
- Basic UDI-DI
- 697849931RFZJ015F EUDAMED
- Direct Marketing DI
- 06978499316015 EUDAMED06978499313014 EUDAMED06978499315018 EUDAMED06978499314011 EUDAMED
- EMDN Code
- Q0102050102 DENTAL REBASING RESINS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Ortho Model Resin by Ziyang Rayform 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 | 697849931RFZJ015F | Class I | Active |
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Manufacturer
- Manufacturer
- Ziyang Rayform Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000048108
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (4)
- EUDAMED a71f8c4f-0789-498e-9726-d607dee530e6 61 fields · synced Oct 6, 2026
- EUDAMED 85a233fe-5e25-48f7-a8d3-8d55247fa7ab 61 fields · synced May 17, 2026
- EUDAMED 67b849e3-b0c5-4227-b344-fbeec9b1d646 61 fields · synced May 18, 2026
- EUDAMED bf55218c-d992-4c32-8116-a17f8be7559e 61 fields · synced May 18, 2026