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Model Resin
EUDAMEDClass I (EU MDR)
Ref RF-MI-1101-04Model RF-MI-1101Ref RF-ZX-03-01Model RF-ZX-03Ref RF-ZX-03-04Ref RF-MI-2103-02Model RF-MI-2103Ref RF-MI-1101-03Ref RF-ZX-03-03Ref RF-MI-2103-04Ref RF-MI-2103-01
Identity
- Trade Name
- Model Resin EUDAMED
- Device Name
- Model Resin EUDAMED
- Model / Reference
- RF-MI-1101 EUDAMEDRF-MI-1101-04 EUDAMEDRF-ZX-03 EUDAMEDRF-ZX-03-01 EUDAMEDRF-ZX-03-04 EUDAMEDRF-MI-2103 EUDAMEDRF-MI-2103-02 EUDAMEDRF-MI-1101-03 EUDAMEDRF-ZX-03-03 EUDAMEDRF-MI-2103-04 EUDAMEDRF-MI-2103-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978499316114 EUDAMED06978499313038 EUDAMED06978499316039 EUDAMED06978499314233 EUDAMED06978499315117 EUDAMED06978499315032 EUDAMED06978499316237 EUDAMED06978499313236 EUDAMED
- Basic UDI-DI
- 697849931RFMI1101K5 EUDAMED697849931RFZX037R EUDAMED697849931RFMI2103KG EUDAMED
- Direct Marketing DI
- 06978499316114 EUDAMED06978499313038 EUDAMED06978499316039 EUDAMED06978499314233 EUDAMED06978499315117 EUDAMED06978499315032 EUDAMED06978499316237 EUDAMED06978499313236 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
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 | 697849931RFMI1101K5 | 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 (8)
- EUDAMED bd8d9101-ace1-4f69-84f3-bc5ce773b76e 61 fields · synced Aug 3, 2026
- EUDAMED 1687357e-54a4-47a4-a536-71b0e46978e4 61 fields · synced May 11, 2026
- EUDAMED 2b4a46c1-953f-4661-bace-256b4c972474 61 fields · synced May 17, 2026
- EUDAMED b05ebdd3-af01-40d1-bb7a-49c6eb5de760 61 fields · synced May 17, 2026
- EUDAMED c7d600dd-ba25-405d-af01-0a6fcf8b2966 61 fields · synced May 17, 2026
- EUDAMED 3c1fc60f-0bca-4d9d-8e85-556ab2258928 61 fields · synced May 17, 2026
- EUDAMED 63a37912-6c09-47b2-a14c-813cd501b8e0 61 fields · synced May 18, 2026
- EUDAMED 95b2aa84-eda6-41a6-8027-a9624bb1f50f 61 fields · synced May 19, 2026