Identity
- Trade Name
- Dental Surgical Guide Resin EUDAMED
- Device Name
- Dental Surgical Guide Resin EUDAMED
- Model / Reference
- SG100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922572200036 EUDAMED
- Basic UDI-DI
- 69225722SG100K8 EUDAMED
- EMDN Code
- Q0102050101 TEMPORARY TEETH RESINS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Dental appliance fabrication material, resin
Dental Surgical Guide Resin by Shenzhen Esun Industrial Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69225722SG100K8 | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Esun Industrial Co., Ltd.
- EUDAMED SRN
- CN-MF-000042542
- Authorised Representative
- WISELINK MEDICAL, S.L.U. ES-AR-000052118
Sources (1)
- EUDAMED 0327fc0e-57d1-4c61-9958-819ba99bea17 61 fields · synced Jul 24, 2026