Identity
- Trade Name
- Dentin Etchant Gel EUDAMED
- Device Name
- Super-Bond EUDAMED
- Model / Reference
- T056E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560227801782 EUDAMED
- Basic UDI-DI
- B-04560227801782 EUDAMED
- EMDN Code
- Q0101010299,Q010407 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dentin Etchant Gel by Sun Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04560227801782 | 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 8a10301e-c197-45c1-baaf-819cfe4a976c 61 fields · synced Jun 18, 2026