Identity
- Trade Name
- Custom Tray Resin EUDAMED
- Device Name
- Custom Tray Resin EUDAMED
- Model / Reference
- CT100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922572200029 EUDAMED
- Basic UDI-DI
- 69225722CT100GK EUDAMED
- EMDN Code
- Q0102050199 DENTISTRY RESINS - OTHER 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
Custom Tray Resin by Shenzhen Esun Industrial 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 | 69225722CT100GK | 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 69be5f2b-063d-4238-8394-eaef690bf62d 61 fields · synced Jun 19, 2026