Identity
- Trade Name
- Super-Bond Universal Kit EUDAMED
- Device Name
- Super-Bond EUDAMED
- Model / Reference
- K058TR EUDAMEDK058E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560227800761 EUDAMED04560227800754 EUDAMED
- Basic UDI-DI
- B-04560227800761 EUDAMEDB-04560227800754 EUDAMED
- EMDN Code
- Q0101010299,Q010407 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMEDFrance 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
Super-Bond Universal Kit 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-04560227800761 | 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 (2)
- EUDAMED e287d478-5323-49e7-a434-02b5b4bc37dd 61 fields · synced Jul 12, 2026
- EUDAMED 80c6c4f4-4f18-4b39-8127-ee5757b45413 61 fields · synced May 19, 2026