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Soft Splint Resin
EUDAMEDClass I (EU MDR)
Ref RF-SS-13-02Model RF-SS-13Ref RF-SS-13-01Ref RF-SS-13-03
Identity
- Trade Name
- Soft Splint Resin EUDAMED
- Device Name
- Soft Splint Resin EUDAMED
- Model / Reference
- RF-SS-13 EUDAMEDRF-SS-13-02 EUDAMEDRF-SS-13-01 EUDAMEDRF-SS-13-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978499314134 EUDAMED06978499313137 EUDAMED06978499315131 EUDAMED
- Basic UDI-DI
- 697849931RFSS135J EUDAMED
- Direct Marketing DI
- 06978499314134 EUDAMED06978499313137 EUDAMED06978499315131 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
Soft Splint 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 | 697849931RFSS135J | 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 89763476-f61b-40ba-8390-b521b0f28242 61 fields · synced Jul 31, 2026
- EUDAMED 2b5db592-65a4-482c-b590-9fdb9b7032b8 61 fields · synced May 18, 2026
- EUDAMED a2e8ce17-b798-44da-b3e4-3fd07c3826f3 61 fields · synced May 19, 2026