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IBT Resin
EUDAMEDClass I (EU MDR)
Ref RF-IR-14-01Model RF-IR-14Ref RF-IR-14-04Ref RF-IR-14-02Ref RF-IR-14-03
Identity
- Trade Name
- IBT Resin EUDAMED
- Device Name
- IBT Resin EUDAMED
- Model / Reference
- RF-IR-14 EUDAMEDRF-IR-14-01 EUDAMEDRF-IR-14-04 EUDAMEDRF-IR-14-02 EUDAMEDRF-IR-14-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978499313144 EUDAMED06978499316145 EUDAMED06978499314141 EUDAMED06978499315148 EUDAMED
- Basic UDI-DI
- 697849931RFIR1439 EUDAMED
- Direct Marketing DI
- 06978499313144 EUDAMED06978499316145 EUDAMED06978499314141 EUDAMED06978499315148 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
IBT 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 | 697849931RFIR1439 | 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 cd77fcd0-e856-4c1c-9828-157b0c791b4f 61 fields · synced Jul 29, 2026
- EUDAMED 53509b56-0701-4dfd-83a8-f41ae0d1c523 61 fields · synced May 18, 2026
- EUDAMED 39f32bee-6fda-42fb-8b1a-6947bc8a3c23 61 fields · synced May 18, 2026
- EUDAMED 76e80653-dbb0-45d8-9996-7abb4d6a86c3 61 fields · synced May 18, 2026