Identity
- Trade Name
- GeneTM Set EUDAMED
- Model / Reference
- GTS 3 EUDAMEDT5006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069150065 EUDAMED
- Basic UDI-DI
- B-08800069150065 EUDAMED
- EMDN Code
- A1102,W0104010203 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
GeneTM Set by SG BioScience 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-08800069150065 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- SG BioScience Inc.
- EUDAMED SRN
- KR-MF-000009362
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED cc317716-75c8-4e98-9d94-5f0c42302fa5 61 fields · synced Jun 19, 2026