Identity
- Trade Name
- Surgical Guide Resin EUDAMED
- Device Name
- Surgical Guide Resin EUDAMED
- Model / Reference
- PRS-R-11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978611810124 EUDAMED
- Basic UDI-DI
- 697861181012MS EUDAMED
- EMDN Code
- Q0102050199 DENTISTRY RESINS - OTHER 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
Surgical Guide 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 | 697861181012MS | 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 be00887e-9dce-4ad2-8507-c69616ae0037 61 fields · synced Sep 17, 2026