Identity
- Trade Name
- Enamel Etchant Gel EUDAMED
- Device Name
- Super-Bond EUDAMED
- Model / Reference
- T055TR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560227801775 EUDAMED
- Basic UDI-DI
- B-04560227801775 EUDAMED
- EMDN Code
- Q0101010299,Q010407 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Enamel 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-04560227801775 | 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 a659fb44-f916-4b6c-a434-66019c1c5177 61 fields · synced Jun 19, 2026