Identity
- Device Name
- U-TOP™ MSI Detection Kit EUDAMED
- Model / Reference
- SS-5030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069800014 EUDAMED
- Basic UDI-DI
- B-08800069800014 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
U-TOP™ MSI Detection Kit by SEASUN BIOMATERIALS Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08800069800014 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- SEASUN BIOMATERIALS Inc.
- EUDAMED SRN
- KR-MF-000047160
- Authorised Representative
- SOAR & PARTNERS Sp. z o.o. PL-AR-000040956
Sources (1)
- EUDAMED 9e0f016e-958a-4506-8ca9-cc316d373d50 61 fields · synced Jul 29, 2026