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Surgical Guide Resin
EUDAMEDClass I (EU MDR)
Ref RF-DB-04-01Model RF-DB-04Ref RF-DB-04-03Ref RF-DB-04-04
Identity
- Trade Name
- Surgical Guide Resin EUDAMED
- Device Name
- Surgical Guide Resin EUDAMED
- Model / Reference
- RF-DB-04 EUDAMEDRF-DB-04-01 EUDAMEDRF-DB-04-03 EUDAMEDRF-DB-04-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978499313045 EUDAMED06978499315049 EUDAMED06978499316046 EUDAMED
- Basic UDI-DI
- 697849931RFDB04XG EUDAMED
- Direct Marketing DI
- 06978499313045 EUDAMED06978499315049 EUDAMED06978499316046 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
Surgical Guide 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 | 697849931RFDB04XG | 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 (3)
- EUDAMED 33d2d807-4137-422d-a5b9-0b2faf85d18f 61 fields · synced Aug 1, 2026
- EUDAMED 3fe88264-02db-48d3-befe-2d783df99946 61 fields · synced May 18, 2026
- EUDAMED 47dde64a-ab26-4733-b667-e3522af2f584 61 fields · synced May 19, 2026