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GeneTM Set
EUDAMEDClass IVD General (EU MDR)
Ref T5582Model GTB 5Ref T5587Model GTB 8Ref T5002Model GTS 1Ref T5001Model GTS 2Ref T5586Model GTB 7Ref T5501Model GTB 2
Identity
- Trade Name
- GeneTM Set EUDAMED
- Model / Reference
- GTB 5 EUDAMEDT5582 EUDAMEDGTB 8 EUDAMEDT5587 EUDAMEDGTS 1 EUDAMEDT5002 EUDAMEDGTS 2 EUDAMEDT5001 EUDAMEDGTB 7 EUDAMEDT5586 EUDAMEDGTB 2 EUDAMEDT5501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069155824 EUDAMED08800069155879 EUDAMED08800069150027 EUDAMED08800069150010 EUDAMED08800069155862 EUDAMED08800069155015 EUDAMED
- Basic UDI-DI
- B-08800069155824 EUDAMEDB-08800069155879 EUDAMEDB-08800069150027 EUDAMEDB-08800069150010 EUDAMEDB-08800069155862 EUDAMEDB-08800069155015 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-08800069155824 | 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 (6)
- EUDAMED 9b334284-2d72-402e-b1b1-ad3f18999af2 61 fields · synced Jul 25, 2026
- EUDAMED 922aa368-74e4-45da-b9ee-9356c2b8e54f 61 fields · synced May 16, 2026
- EUDAMED 277341f9-502d-4bf6-8894-88d5255a2a5a 61 fields · synced May 17, 2026
- EUDAMED 46fe6e6c-815e-4adf-8ae4-e1a296fb5832 61 fields · synced May 17, 2026
- EUDAMED fe9b2cdd-d83c-491a-98f0-a667b35b9b83 61 fields · synced May 17, 2026
- EUDAMED 8cf90ef9-f420-4a60-9700-6ba8265e87e6 61 fields · synced May 19, 2026