Identity
- Trade Name
- Gel Desensitizer EUDAMED
- Device Name
- Gel Desensitizer EUDAMED
- Model / Reference
- T931E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560227802857 EUDAMED
- Basic UDI-DI
- 456022779DM50100000ET EUDAMED
- Direct Marketing DI
- 04560227802895 EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Gel Desensitizer by Sun Medical Co., Ltd. — Class IIa — 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 | 456022779DM50100000ET | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sun Medical Co., Ltd.
- EUDAMED SRN
- JP-MF-000011109
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED d57b4d5e-b64e-4d14-9259-08123eec74e1 61 fields · synced Jul 25, 2026