Identity
- Trade Name
- IBT Resin EUDAMED
- Device Name
- IBT Resin EUDAMED
- Model / Reference
- PRS-R-09 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978611810131 EUDAMED
- Basic UDI-DI
- 697861181013MU EUDAMED
- EMDN Code
- Q0102050102 DENTAL REBASING RESINS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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 Shenzhen Zhongchuang 3D 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 | 697861181013MU | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Zhongchuang 3D Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000048153
- Authorised Representative
- WISELINK MEDICAL, S.L.U. ES-AR-000052118
Sources (1)
- EUDAMED 1d4324bc-616c-49ef-948e-2084fd5eabf5 61 fields · synced Aug 2, 2026